clinical study manager

Teva Pharmaceuticals

<div><div><div><div><p>Apply now &raquo;</p>
</div></div><div><div><div><div><div><p>Clinic Study Manager
</p></div></div></div></div><div></div><div><div><div><div><b>Date: </b>Feb 23, 2026
</div></div></div></div><div><div><div><div><b>Location:
</b>Miramar, United States, Florida, 33025
</div></div></div></div><div><div><div><div><b>Company: </b>Teva Pharmaceuticals
</div></div></div></div><div><div><div><div><b>Job Id: </b>66527
</div></div></div></div><div><div><div><div><div><div><div><div><b>We Are Teva</b></div>
</div><div><div>
We&rsquo;re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it&rsquo;s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we&rsquo;re dedicated to addressing patients&rsquo; needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.</div></div></div><div><div><div><b>
The opportunity</b></div>
</div><div><div><b>
Job Summary:</b><br>
The Clinical Study Manager oversees and maintains the successful execution of a clinical study from project start-up and protocol drafting to completion of the study, CSR drafting/review, and close-out with IRB. During study conduct, the Clinical Study Manager directs and coordinates the clinical operations study team to ensure that all study activities are conducted in accordance with Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable, while emphasizing strict compliance with the study protocol at all times.</div><div><br>
<b>
Essential Functions</b></div>
<ul>
<li>Serves as the primary internal point of contact for all issues related to trial conduct</li>
<li>Collaborates with the Principal Investigator (PI) to provide leadership and project guidance for the study conduct team</li>
<li>Coordinates and communicates study status throughout the study and is responsible for planning and supervising study conduct from study award through delivery of the final Clinical Study Report (CSR) followed by IRB Study close-out</li>
<li>Liaises with the study Sponsor and/or their representatives, including third-party vendors as needed, ensuring that client timelines and deliverables are met throughout all stages of the study conduct</li>
<li>Personally reviews draft protocols and coordinates their review by the PI and pertinent site staff and compiles those comments and suggestion from all departments for provision to the study Sponsor and/or protocol writers</li>
<li>Reviews all study documentation including but not limited to, Informed Consent, CRF's and clinic training to ensure compliance with Final protocol</li>
<li>Ensures that significant study related issues (i.e. Serious Adverse Events, issues pertaining to the protocol, SOPs, or regulatory deviations and/or violations) are escalated to the PI, IRB and the study Sponsor, as appropriate, in a timely manner</li>
<li>Participates in the operational planning and implementation of study design and preparedness, oversees its appropriate organization, scheduling, and execution Provides the PI, study Sponsor, as well as members of clinic management and operational teams, continuous updates regarding timelines and deliverables, regulatory submissions, subject safety, study milestones, recruitment and screening updates, conduct activities, data entry/coordination, and study closeout</li>
<li>Oversees, coordinates and participates in the execution of study trials including activities related to protocol procedures, regulatory requirements, administrative actions, and study close-outs, as needed</li>
<li>Coordinates with other clinic departments that contribute to development of data tables and delivery of Case Report Forms for inclusion into CSR</li>
<li>Personally compiles necessary study information and prepares data tables for inclusion into CSR</li>
<li>Works with clinic staff scheduling department to ensure that the appropriate resources are available for study project success</li>
<li>Provides operational and participatory support</li>
</ul></div></div><div><div><div><b>Your experience and qualifications</b></div>
</div><div><div>
Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.</div><br>
<div></div>
<div>
Education:</div>
<ul>
<li>A bachelors degree or a R.N or L.P.N</li>
</ul>
<div>Experience:</div>
<ul>
<li>Minimum of two years of experience working in a clinical research environment is required.</li>
</ul>
<div>Certification/Licensure:</div>
<ul>
<li>CCRC, CRP or CRA certification is preferred.</li>
</ul>
<div>Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to perform the essential functions of the job)</div>
<ul>
<li>Possesses working knowledge of medical terminology</li>
<li>Able to obtain vital signs and perform ECGs</li>
<li>Able to use advanced scientific interpretation</li>
<li>Capable of performing basic accounting tasks</li>
<li>Able to provide excellent customer service while maintaining a professional attitude with both external clients and site staff</li>
<li>Proficient in MS Office (e.g. Word, Excel, Power Point, Outlook)</li>
<li>Able to work independently and handle multiple competing priorities</li>
<li>Possesses excellent organizational and time-management skills and a strong attention to detail</li>
<li>Able to speak, read, and write English fluently; Bilingual (English/Spanish) beneficial</li>
</ul>
<div>Physical Requirements and Working Conditions:</div>
<ul>
<li>Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 50 pounds.</li>
</ul>
<div>Physical Demands:</div>
<ul>
<li>Routine keyboarding</li>
<li>Variable hours including nights and weekends</li>
</ul>
<div>Work Environment:</div>
<ul>
<li>Office environment and clinical environment</li>
<li>Non-supervisory, non-managerial</li>
</ul></div></div><div><div><div><b>How We&rsquo;ll Take Care of You</b></div>
</div><div><div>
We offer a competitive benefits package, including:<br>
<ul><li>Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.</li><li>Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.</li><li>Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.</li><li>Life and Disability Protection: Company paid Life and Disability insurance.</li><li>Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.</li></ul></div></div></div><div><div><div><b>
Already Working @TEVA?</b></div>
</div><div><div>
If you are a current Teva employee, please apply using the internal career site available on &quot;Employee Central&quot;. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
</div><div>The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.</div></div></div><div><div><div><b>
Teva&rsquo;s Equal Employment Opportunity Commitment</b></div>
</div><div><div>
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.</div><div><br>
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.</div><br>
<div></div>
<div><b>
Important notice to Employment Agencies - Please Read Carefully</b><br>
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</div></div></div></div>
</div></div></div></div></div><p></p><div><p>Apply now &raquo;</p></div></div></div><div></div>

Clinic Study Manager

Otsuka

<div></div><div><div>Job Summary</div><div>
Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget.</div><div></div><div>
Job Description</div><ul><li>Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs.</li><li>Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents.</li><li>Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.</li><li>Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs.</li><li>Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments.</li><li>Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.</li><li>Participate in forecasting study expenditures and resourcing needs.</li><li>Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.</li><li>Provide timely communication of any variances in budget forecast to the Director/Associate Director.</li><li>Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.</li><li>Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned.</li><li>Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency.</li><li>Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF.</li><li>Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned.</li><li>Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities.</li><li>Represent Clinical Management in departmental and cross-functional initiatives, as assigned.</li><li>Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.</li><li>May have supervisory responsibilities including:</li></ul><div>
o Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.</div><div>
o Assuring compliance with departmental, SOP, compliance, and corporate training</div><div>
o Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.</div><div>
o Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.</div><ul><li>Performs other duties, as assigned.</li></ul><div></div><div>
Qualifications/ Required</div><div>
Knowledge/ Experience and Skills:</div><ul><li>Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations.</li><li>Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).</li><li>Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management.</li><li>Strong understanding of global regulatory requirements.</li><li>Strong communication, organization, planning, analytical, problem solving, and people management skills.</li><li>Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.)</li><li>Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).</li><li>Ability to travel up to 25%.</li></ul><div></div><div>
Educational Qualifications</div><div>
Required:</div><ul><li>Bachelor&rsquo;s Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience.</li></ul><div>
Preferred:</div><ul><li>Previous supervisory experience.</li></ul><div>
Competencies<br>
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.<br>
Strategic Thinking &amp; Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.<br>
Patient &amp; Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.<br>
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.<br>
Respectful Collaboration - Seek and value others&rsquo; perspectives and strive for diverse partnerships to enhance work toward common goals.<br>
Empowered Development - Play an active role in professional development as a business imperative.</div><div></div>
Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate&rsquo;s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.<div></div><div><div><div><div><div><div><div><div>
Application Deadline: This will be posted for a minimum of 5 business days.</div></div></div></div></div></div></div></div><div></div><div>
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death &amp; dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.</div><div></div><div>
Come discover more about Otsuka and our benefit offerings; <div>https://www.otsuka-us.com/careers-join-otsuka</div>.</div><div></div><div><div><div><div>
Disclaimer:</div><div></div><div><div><div><br>
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.</div></div><div></div><div><div><br>
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.</div></div><div></div><div><div><br>
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting <div>Accommodation Request</div>.</div></div></div></div></div></div><div></div><div>
Statement Regarding Job Recruiting Fraud Scams</div><div></div><div>
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.</div><div></div><div>
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.</div><div></div><div>
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.</div><div></div><div>
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website <div>https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External</div>.</div><div></div><div>
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka&rsquo;s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: <div>https://www.ic3.gov</div>, or your local authorities.</div><div></div><div>
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development &amp; Commercialization, Inc., and Otsuka Precision Health, Inc. (&ldquo;Otsuka&rdquo;) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka&rsquo;s application portal without a valid written search agreement in place for the position will be considered Otsuka&rsquo;s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</div></div>

Senior Manager, Clinical Management- Early Phase

Thermo Fisher Scientific

<div><p><b>Work Schedule</b></p>
Standard (Mon-Fri)<p></p><p><b>
Environmental Conditions</b></p>
Office<p></p><p><b>
Job Description</b></p><p></p><h2 class="jobSectionHeader"><b>
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.</b></h2><div><h2 class="jobSectionHeader"><b>
Our global Clinical Operations colleagues within our PPD&reg; clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.</b></h2><h2 class="jobSectionHeader"><b>
The PPD FSP Solution:</b></h2><h2 class="jobSectionHeader"><b>
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.</b></h2><h2 class="jobSectionHeader"><b>
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.</b></h2><h2 class="jobSectionHeader"><b>
Discover Impactful Work:</b></h2><p></p><h2 class="jobSectionHeader"><b>
Accountable for achieving the final clinical deliverable (usually clean data from evaluated patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs.</b></h2><h2 class="jobSectionHeader"><b>
A day in the Life:</b></h2><ul><li><h3 class="jobSectionHeader"><b>
Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff, and external clinical site staff involved in study preparation and delivery providing both matrix leadership and project management of study activities within the country(ies).</b></h3></li><li><h3 class="jobSectionHeader"><b>
Serves as the operational point-of-contact between the central study team and within-country(ies) study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country(ies). Leads selection of sites within country(ies) and is accountable for local study performance.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Accountable for within-country delivery of assigned studies to time, budget, and quality expectations as defined in the clinical development plan and study protocol as well as in local/regional regulations, IND/GCP/ICH-guidelines, and procedures. Ensures quality and integrity of clinical studies by taking on appropriate business management monitoring activities.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Ensures development and maintenance of country study plan and that critical study timelines related to study activities within-country(ies) are accurately forecasted and achieved, including budgets, resource estimates, milestones, timelines, quality and risk planning, and that recruitment targets, patient recruitment cycle times, data, and audit/inspection quality are met. Provides troubleshooting and problem resolution support for within-country study team to ensure productive, efficient study delivery. Ensures necessary supplies are available at sites and manages local supply inventory.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders and to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators, and other reports. Review all study databases to ensure 100% accuracy.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Ensures development of country/site-level risk assessment to proactively identify risks, develop a mitigation plan, and escalate issues and risks that may impact study delivery.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.</b></h3></li><li><h3 class="jobSectionHeader"><b>
May provide feedback on performance, capabilities, and competencies of local study members to line management.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Has the accountability to create and manage study budgets (budget updates, expenditures including site payments across a study) and estimate, track, and deliver against the local budget for the studies within their scope of responsibility. As required, advises support/develops and negotiates on contract development with Sites/CRO/Vendors ensuring legal input where required and may participate in budget/contract negotiations with study vendors or clinical investigator sites. As required, selects &amp; manages local vendors in accordance with local practices &amp; in alignment with overall resourcing strategy for the study; accountable for local vendor management including oversight, agreements, payments, communications &amp; issue management.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Manages the development of key study documents, plans &amp; manuals according to local requirements (monitoring plan, local informed consent form, import/export licenses, etc.). May provide input into the study concept, protocol, logistics, and may coordinate other expert local input. As required, may arrange accurate translations of key study documentation into the local language.</b></h3></li><li><h3 class="jobSectionHeader"><b>
As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study. May also be accountable for Regulatory Authority submissions and approvals.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of the disease area being studied, competitive landscape within country(ies), local treatment/immunization guidelines, and local health care system requirements, as well as study protocol training and all study-related activities. Participate continuously in relevant training courses to improve personal/professional skills.</b></h3></li><li><h3 class="jobSectionHeader"><b>
As required, assists with audits/inspections of local clinical operations department and study/sites in the country(ies). May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response &amp; follow-up to assessment/audit reports.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Continuously develops and keeps up-to-date knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site, and project management skills and capabilities. Responsible to identify and share standard processes.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Open to travel as needed for the role.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Ensures appropriate training of in-country staff and investigator sites; coordinates &amp; delivers operational aspects at local study meetings including investigator meetings, monitor meetings, and local training.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Escalates resourcing issues to ensure that in-country study activities are appropriately resourced.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Ensures robust communication and engagement with sites, e.g., timely communication of protocol amendments.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Ensures ongoing management and reporting of study-specific safety issues and safety report handling, as required (including SAE reporting).</b></h3></li><li><h3 class="jobSectionHeader"><b>
Coordinates/contributes to end-of-study/program learning debriefs and identifies areas for improvement.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Interact and collaborate with country study staff and staff from other functions as needed (e.g., Medical, legal, finance, etc.).</b></h3></li><li><h3 class="jobSectionHeader"><b>
Communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Interactions with key partners including ethics boards, pharmacies, vendors.</b></h3></li></ul><h2 class="jobSectionHeader"><b>
Keys to Success:</b><br>
</h2><h2 class="jobSectionHeader"><b>
Education</b></h2><ul><li><h3 class="jobSectionHeader"><b>
Bachelor's degree or equivalent and relevant formal academic / vocational qualification</b></h3></li></ul><p></p><h2 class="jobSectionHeader"><b>
Experience</b></h2><ul><li><h3 class="jobSectionHeader"><b>
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).</b></h3></li><li><h3 class="jobSectionHeader"><b>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Experience in site monitoring</b></h3></li></ul><h2 class="jobSectionHeader"><b>
Knowledge, Skills, Abilities</b></h2><ul><li><h3 class="jobSectionHeader"><b>
Demonstrates flexibility and resilience with the ability to evolve in an always changing and challenging (internal and external) environment, processes, and systems.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Demonstrates excellent leadership skills, promoting motivation and high-quality performance of others to accomplish individual, team, and organizational objectives.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Demonstrates an excellent understanding of clinical study, drug development, sample management, and other associated processes and quality requirements.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Has a strong project management approach and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Proficient in acting as the organization's spokesperson to external physician investigators and other external clinical site staff, institutional review boards, etc., including responding to intricate questions.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Capable of performing well within the local setting and, if needed, in additional regional settings while encouraging positive relationships with remote central team members. Ability to work effectively in a remote environment.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Capable of establishing and coordinating priorities and performance objectives in a nearby setting and, when necessary, in additional regional settings.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Effectively plans, communicates, coordinates, and facilitates delivery of local/regional team objectives.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Demonstrates a solid understanding of country local regulations and, if required, basic understanding of other countries' regulations, ICH-GCP guidelines, and written standards.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Available and willing to travel for project-related activities as required (e.g., Investigator &amp; Monitors Meeting attendance).</b></h3></li><li><h3 class="jobSectionHeader"><b>
Acts as a role model in line with the organization's culture, including values and behaviors.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Able to understand and apply new digital innovations to clinical trials.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Able to demonstrate conceptual, analytical, and strategic thinking including data literacy.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Effective at problem-solving and conflict resolution.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Demonstrates fluency in Arabic and good English language written and verbal communication skills in addition to proven negotiation skills.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Demonstrates flexibility with high learning agility.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Demonstrates strong computer skills and the ability and willingness to learn and master new or evolving computer systems to support business requirements effectively.</b></h3></li></ul><h2 class="jobSectionHeader"><b>
Apply today! </b><b>http://jobs.thermofisher.com</b></h2><p></p><h2 class="jobSectionHeader"><b>
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.</b><br>
</h2><h2 class="jobSectionHeader"><b>
Accessibility/Disability</b><b> Access</b></h2><h2 class="jobSectionHeader"><b>
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.</b><br>
</h2><ul><li><b>This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.</b></li></ul></div></div><p></p>

Local Clinical Trial Manager - FSP, Saudi Arabia

ICON plc

<div>Centralized Clinical Trial Manager<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Centralized Clinical Trial Manager to join our diverse and dynamic team. As a Centralized Clinical Trial Manager at ICON, you will play a crucial role in overseeing the centralized monitoring activities of clinical trials, ensuring the smooth coordination of data-driven insights to enhance trial quality and patient safety. You will contribute to the advancement of innovative treatments and therapies by managing centralized trial activities and collaborating with cross-functional teams to ensure study compliance and efficiency.</div><div></div><div>
Location: Bangalore or Chennai ( Home Based or Office Based)</div><div></div><div>
What You Will Be Doing:</div><div></div><ul><li>
Leading the centralized monitoring activities for clinical trials, including data review and risk-based monitoring.</li><li>
Collaborating with Clinical Operations, Clinical Trial Management and Project Management teams to identify potential monitoring risks and ensuring proactive escalation of monitoring issues.</li><li>
Ensuring study compliance with regulatory requirements and protocols by overseeing real-time data reviews and monitoring activities.</li><li>
Providing oversight on site performance, patient safety, and data quality through focused monitoring data insights and analytics.</li><li>
Coordinating with cross-functional teams to ensure efficient execution of clinical trials and contribute to continuous improvement in trial processes.</li></ul><div></div><div>
Your Profile:</div><ul><li>
Bachelor&rsquo;s degree in life sciences, healthcare, or a related field (advanced degree preferred).</li><li>
Minimum 8-10 years of Clinical Research experience with at-least 5 years of on-site monitoring experience.</li><li>
Experience in On-Site Monitoring and Clinical Trial Management, with a solid understanding of on-site monitoring approaches.</li><li>
Strong analytical skills with proficiency in clinical trial data review and interpretation.</li><li>
Excellent organizational and project management skills, with the ability to manage multiple studies and meet deadlines.</li><li>
Effective communication and interpersonal skills, with the ability to collaborate across diverse teams and functions.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Centralized Clinical Trial Manager

<div>US, Senior Clinical Research Associate, Sponsor Dedicated<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Senior Clinical Research Associate in the Midwest Region to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a key role in early-phase clinical trials, working closely with Clinical Operations leadership and study teams. This is not a narrowly defined, process-heavy role. You will have the opportunity to contribute broadly, problem-solve in real time, and help shape how Phase I studies are executed.</div><div></div><div>
What You Will Be Doing:</div><ul><li><div>
Hands-on involvement across Phase I study start-up, conduct, and close-out</div></li><li><div>
Monitor Phase I clinical trials (on-site and remote)</div></li><li><div>
Support study start-up, site activation, and ongoing site management</div></li><li><div>
Autonomy to manage sites and priorities in a dynamic environment</div></li><li><div>
Exposure to complex early-phase activities and decision-making</div></li><li><div>
Ensure protocol compliance, data integrity, and GCP adherence</div></li><li><div>
Proactively identify and resolve site and study-level issues</div></li><li><div>
Partner closely with Clinical Operations and cross-functional teams</div></li></ul><div>
Your Profile:</div><ul><li><div>
Bachelor's degree in a scientific or healthcare-related field.</div></li><li><div>
Minimum of 2 years of experience as a Clinical Research Associate for a biotech, pharmaceutical company or CRO</div></li><li><div>
Previous CRA experience with Phase I / early-phase trials required</div></li><li><div>
Are comfortable pivoting and working in evolving environments</div></li><li><div>
Strong knowledge of GCP and early-phase clinical trial conduct</div></li><li><div>
Ability to manage multiple priorities independently</div></li><li><div>
Strong communication, adaptability, and problem-solving skills</div></li><li><div>
Are motivated by learning, growth, and visible impact</div></li><li><div>
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

US, Senior Clinical Research Associate, Sponsor Dedicated

<div>US, Senior Clinical Research Associate, Sponsor Dedicated<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Senior Clinical Research Associate in the Midwest Region to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a key role in early-phase clinical trials, working closely with Clinical Operations leadership and study teams. This is not a narrowly defined, process-heavy role. You will have the opportunity to contribute broadly, problem-solve in real time, and help shape how Phase I studies are executed.</div><div></div><div>
What You Will Be Doing:</div><ul><li><div>
Hands-on involvement across Phase I study start-up, conduct, and close-out</div></li><li><div>
Monitor Phase I clinical trials (on-site and remote)</div></li><li><div>
Support study start-up, site activation, and ongoing site management</div></li><li><div>
Autonomy to manage sites and priorities in a dynamic environment</div></li><li><div>
Exposure to complex early-phase activities and decision-making</div></li><li><div>
Ensure protocol compliance, data integrity, and GCP adherence</div></li><li><div>
Proactively identify and resolve site and study-level issues</div></li><li><div>
Partner closely with Clinical Operations and cross-functional teams</div></li></ul><div>
Your Profile:</div><ul><li>
Advanced degree in a relevant field such as life sciences, nursing, or medicine.</li><li>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</li><li>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</li><li>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</li><li><div>
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Regeneron

<div><p>The Manager, Clinical Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management results that meet Regeneron standards and within timelines.
</p><p></p><h2 class="jobSectionHeader"><b>A typical day might include the following:
</b></h2><ul><li>Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects.
</li><li>Supervises direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality results and within the budget. Mentor junior data managers for skills advancement. If required, leads and performs clinical data management tasks for studies.
</li><li>Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP&rsquo;s and work instructions in compliance with applicable regulations.
</li><li>Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.
</li></ul><p></p><h2 class="jobSectionHeader"><b>This role might be for you if:
</b></h2><ul><li>Supervises DM direct reports for the initiation and approval of the building, and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Coordinates with clinical project team for issue resolution.
</li><li>Contributes to development of Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
</li><li>Ensures adequate management of CROs and vendors in the therapeutic projects and coordinates all data management functions.
</li><li>Establishes goals, expectations and accountabilities for direct reports. Regularly reviews DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures. Responsible for coaching, handling training and leading the direct reports.
</li></ul><p></p><h2 class="jobSectionHeader"><b>To be considered
</b></h2><ul><li>Bachelor&rsquo;s degree in mathematics, Science or a related field, along with at least 8 or more years of clinical data management experience in biotech, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus. Previous managerial experience is preferred
</li><li>Directed and comfortable working in teams with the ability to work and operate independently within a tight time line environment. High degree of creativity, latitude and attention to detail required.
</li><li>Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong communication, leadership and business development skills required.
</li><li>Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus.
</li></ul><p></p><div><div><div><div><div><div><div><p>Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries&rsquo; specific benefits, please speak to your recruiter.
<br>
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron&rsquo;s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron&rsquo;s on-site policy and expectations for your role and your location.<br>
<br>
</p><p></p><p>Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
</p><p></p><p>For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
</p><p></p><p>Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
</p><p></p><p><b>Salary Range (annually)
</b></p></div></div></div></div></div></div></div>$114,800.00 - $187,400.00</div>

Mgr CDM Study Lead

Search 10000+ Clinical study manager jobs near you this March. New roles added regularly across leading industries. Apply today.

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US, Senior Clinical Research Associate, Sponsor Dedicated

US, Senior Clinical Research Associate, Sponsor Dedicated

Mgr CDM Study Lead