clinical project manager

IQVIA

<div><div><div>Riyadh, Saudi Arabia | Full time | Hybrid | R1529346</div></div><p></p><div><div><b><br>
Project Leads</b> are an integral part of clinical trial delivery, liaising with clinical teams to improve patients&rsquo; lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.</div><div><b>
Clinical Project Management </b>is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA&rsquo;s suite of solutions to drive operational excellence and strategic leadership with our customers.</div><div><b>
Main Responsibilities</b><br>
<ul><li>Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.</li><li>Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.</li></ul></div><ul><li>Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.</li><li>May be responsible for delivery and management of smaller, less complex, regional studies.</li><li>Develop integrated study management plans with the core project team.</li><li>Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.</li><li>Monitor progress against contract and prepare project information proactively to stakeholders internally and externally.</li><li>Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.</li><li>Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and implementing appropriate corrective and preventative action plans.</li><li>Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.</li><li>Ensure the financial success of the project.</li><li>Identify changes in scope and manage change control process as necessary.</li><li>Support staff development and mentor less experienced project team members.</li></ul><div><b>
Required Skills and Qualifications</b><br>
<ul><li>Bachelor's Degree Life sciences or related field.</li><li>5 years of prior relevant experience including at least 2 years of prior work experience in a Senior Clinical Research Associate role.</li></ul></div><ul><li>At least 1 years project management experience or equivalent combination of education, training and experience is preferred.</li><li>Therapeutic area knowledge in any of the following would be an advantage: oncology, rare diseases is preferred.</li><li>Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.</li><li>Good understanding of project financials including experience managing, contractual obligations and implications.</li><li>Strong written and verbal communication skills including very good command of English and Arabic language.</li><li>Strong customer service skills and presentation abilities.</li><li>Planning, time management and prioritization skills.</li><li>Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.</li><li>Good software and computer skills.</li></ul><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div></div><div></div>

Associate Clinical Project 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

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

Indiana University Health

<div><div><div><div><h1 class="jobSectionHeader"><b>Project Manager-Information Services</b></h1>
</div></div><div></div><div><h2 class="jobSectionHeader"><b>Job Description</b></h2>
<div><p><b>Overview</b>
</p><p><b>Project Manager-Information Services</b></p><p><i>
Our leaders shape strategic initiatives, develop passionate teams, and work to improve health outcomes. They advance our mission and exemplify excellence, compassion, teamwork and purpose in all that they do</i><b><i>. </i></b>Indiana University Health is seeking individuals who embody these values to join our Informatics &amp; Information Services leadership team in the role of Project Manager-Information Services. <b>This is a Direct Hire on a hybrid schedule, as needed, from the IU Health Med. Tower.</b></p><p></p><div><b><br>
Scope:</b></div><ul><li><div>
Leads various system project(s) ranging from low to medium complexity which may encompass multiple applications and business area to successful and timely completion and within budget.</div></li><li><div>
This role involves coordinating with multiple teams and governance groups.</div></li><li><div>
Provides administrative decision making, leadership and planning for IU Health's business and clinical projects.</div></li><li><div>
Provides day-to-day coordination, communications, issue/resolution, financial management related to the specific projects.</div></li><li><div>
Oversees resources assigned to the project and must be familiar with the systems scope and project objectives, as well as the role and function of each team member in order to effectively coordinate the activities of the team.</div></li><li><div>
Facilitates current and future state business processes, requirements, elicitation, solutions and development and test management.</div></li></ul><p></p><p><b><br>
Key Relationships:</b></p><ul><li>
Reports to: Director of Information Services.</li></ul><p></p><p><b><br>
Candidate Qualifications:</b></p><ul><li>
Bachelor's Degree preferred or equivalent experience.
</li><li>3-5 years of relevant experience required.
</li><li>Requires an understanding of the Information Management principles, IT processes, Project Management Methodologies, architecture, and technologies adopted by an organization.</li><li>
Required experience with enterprise PPM (Project and Portfolio Management) tools.</li><li>
Strong working skills with MS Office tools such as MS Project, Word, Excel, PowerPoint, Visio etc. are preferred.
</li><li>Preferred experience with contractor and vendor management.</li><li>
Requires a demonstrated fundamental understanding of project accounting and financial management.</li></ul><p></p><p><b><br>
Strongly Preferred Qualifications:</b></p><ul><li>
Experience as a Registered Nurse or other clinical role strongly preferred.</li><li>
Clinical Informatics experience is strongly preferred.</li><li>
At least 3 years&rsquo; experience in project management or relevant experience, preferably in healthcare.</li><li>
Strong coordination, problem-solving, and communication skills.</li><li>
Adaptability to a diverse range of tasks, from technical to managerial.</li><li>
Knowledge of healthcare systems and technology integration.</li><li>
EMR experience in Cerner or Epic.</li></ul><p></p><p><br>
Indiana University Health is unlike any other healthcare system and we're looking for team members who share the things that matter most to us. IU Health leaders play a crucial role in advancing the mission of our organization and inspiring teams to make a meaningful difference in the lives of patients. As one of Indiana&rsquo;s largest employers and the most comprehensive medical system in the state, our vision is <b><i>to lead the transformation of healthcare through quality, innovation and education, and make Indiana one </i></b><b><i>of the nation&rsquo;s healthiest states.</i></b></p><p>
IU Health is the largest health system in Indiana with nearly 40,000 team members, 15 hospitals and $8.64 billion in operating revenue. The system&rsquo;s programs in cancer, cardiovascular, neuroscience, orthopedics, pediatrics and transplants have received national recognition for quality patient care. IU Health, in partnership with the Indiana University School of Medicine, bring together highly skilled physicians, researchers, and educators into close collaboration to provide world-class care for children and adults and improve the health of patients and communities across Indiana.</p><p><b><i>
Indiana University Health is dedicated to a fair hiring process and is committed to equal opportunity and nondiscrimination for all individuals, regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, gender identity, expression, sexual orientation, or veteran status.</i></b></p><br>
</div><p></p><div><p>We are an equal opportunity employer. IU Health does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</p>
</div></div></div><div></div><div><div><div><p>Indiana University Health is Indiana&rsquo;s most comprehensive health system, with 15 hospitals and nearly 40,000 team members serving Hoosiers across the state. Our partnership with the Indiana University School of Medicine gives our team members access to the very latest science and the very best training, advancing care for all. We&rsquo;re looking for team members who share the things that matter most to us. People who are inspired by challenging and meaningful work for the good of every patient. People who are compassionate and serve with a purpose. People who aspire to excellence every day. People who are always ready to apply themselves.</p></div></div></div></div>

Project Manager-Information Services

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

Whitecollars

<div><ul><li><b>Reporting To: </b>Managing Director</li><li><b>
Location &amp; Time Zone:</b> Hybrid</li><li><b>
Contract Type:</b> Full Time</li></ul><h3 class="jobSectionHeader"><b>
Company Overview</b></h3><p>
Our Client is a specialised scientific services organisation focused on supporting healthcare and life sciences clients with high-quality medical communications, medical affairs, education, and data analysis services. The company partners with clients to understand their scientific and commercial needs, delivering clear, impactful scientific content and evidence-based outputs that advance client goals and improve communication across stakeholders. With a commitment to excellence and collaboration, Trillium Sciences bridges scientific expertise with strategic insights to help clients succeed in complex healthcare environments.
</p><p></p><h3 class="jobSectionHeader"><b>Job Summary</b></h3><p>
The Medical Project Manager is a hybrid role that blends business development with scientific project management. The role focuses on building strong client relationships while delivering high-quality projects across medical communications, RWE, clinical research, and scientific consultancy. Being a key link between clients, scientific teams, and leadership, you will ensure projects are executed on time, in compliance, and in alignment with commercial objectives.</p><p></p><h3 class="jobSectionHeader"><b><br>
Key Responsibilities:</b></h3><ul><li><p>
Drive client acquisition and growth by identifying prospects, qualifying leads, supporting pitches, and contributing to proposals, SOWs, budgets, and timelines.</p></li><li><p>
Build and maintain strong client relationships to enable repeat business, project expansion, and effective understanding of scientific and commercial needs.</p></li><li><p>
Collaborate with leadership on pricing strategy, service positioning, and market intelligence while representing the organization at scientific and industry events.</p></li><li><p>
Lead end-to-end planning and execution of scientific and medical projects across medical writing, RWE studies, and advisory/consensus initiatives.</p></li><li><p>
Coordinate cross-functional teams and served as the primary client point of contact to ensure on-time, within-scope, and compliant project delivery.</p></li><li><p>
Oversee project governance, including timelines, risk management, KPI tracking, quality control, documentation, and audit-ready records.</p></li></ul><p></p><h3 class="jobSectionHeader"><b>
Requirements:</b></h3><ul><li><p>
Bachelor&rsquo;s degree in Medicine or Pharmacy, Master's degree or a PhD is a plus.</p></li><li><p>
3&ndash;6 years of experience in medical communications, clinical research, CROs, pharmaceutical companies, or scientific consultancy.</p></li><li><p>
Proven experience in scientific project coordination or management within healthcare or life sciences, including client management and proposal/SOW development.</p></li><li><p>
Strong scientific background with solid understanding of clinical research, medical writing, evidence generation, and publication processes.</p></li><li><p>
Familiarity with real-world evidence (RWE), observational studies, and advisory or consensus projects.</p></li><li><p>
Strong communication, stakeholder management, and client-facing leadership skills with commercial awareness.</p></li><li><p>
Excellent organizational and multitasking skills.</p></li><li><p>
High attention to detail with a strong focus on quality.</p></li><li><p>
Ability to work independently and collaboratively in a fast-paced environment.</p></li><li><p>
Excellent written and verbal communication skills in English.</p></li></ul></div>

Medical Project Manager

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

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