clinical project manager

INSIGHTEC

<div><p>Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.</p><p></p><p><br>
Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values &ndash; Our Patients, Integrity, Team, Quality and Innovation.</p><p></p><p><br>
Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.</p><p></p><p><br>
Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.</p><p></p><p><br>
Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.</p><p></p><p><br>
The Clinical Project Manager serves as the clinical trial lead and will lead clinical trial initiatives for Insightec. You will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams such as Medical Affairs, R&amp;D, and Quality &amp; Regulatory to advance Insightec&rsquo;s clinical pipeline. The Clinical Project Manager is expected to independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe.</p><p></p><p><b><br>
Key Responsibilities:</b></p><ul><li>
Clinical Trial Management:</li><li>
Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.</li><li>
Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence including implementation of best practices such as quality by design.</li><li>
Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports.</li><li>
Support creation of investigator brochures, clinical evaluation reports, publications and other documentation such as annual reports as applicable.</li><li>
In partnership with R&amp;D Program Management, develop and drive cross functional study timelines related to trial setup and execution</li><li>
Other roles/responsibilities will be defined as needed</li></ul><p>
Team Leadership:</p><ul><li>
Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.</li><li>
Successfully interface with Data Management, Biostatistics and Clinical Monitors to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines</li><li>
Foster a collaborative team environment focused on operational efficiency and continuous improvement.</li><li>
Regulatory and Compliance Oversight:</li><li>
Ensure that clinical trials are conducted in compliance with all applicable regulations and ISO 14155 and ICH-GCP guidelines as applicable.</li><li>
Lead submissions of clinical trial documents to central IRB/IECs as applicable and ensure insurance and recruitment materials are prepared appropriately.</li><li>
Support the preparation and submission of clinical trial applications, including IDEs, PMAs, 501K, INDs, and other regulatory documents with functional leads from regulatory affairs.</li><li>
Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.</li><li>
Budget and Resource Management:</li><li>
Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.</li><li>
Monitor and control trial costs to ensure alignment with project forecasts and company objectives.</li><li>
Negotiate contracts and budgets with clinical vendors and investigators.</li><li>
Vendor and Site Management:</li><li>
Oversee the selection and management of clinical research sites and clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.</li><li>
Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.</li><li>
Perform risk assessment and management, addressing issues proactively to mitigate operational issues.</li></ul><p></p><p><b><br>
Qualifications:</b></p><ul><li>
Bachelor's or Master's degree in life sciences or a related field.</li><li>
7+ Years of experience as a Clinical Project Manager for Class II/III device studies</li><li>
3+ years of regulatory/clinical trial experience in the medical device industry</li><li>
Demonstrates working knowledge of clinical trial design</li><li>
Minimum of three years of experience developing clinical documents including protocols, informed consent, clinical study reports, and investigator brochures among other documents.</li><li>
Knowledge of financial principles in budgeting, budget negotiation, &amp; contracts management.</li><li>
Demonstrates data management skills, tracking study metrics, and adherence to study protocol</li><li>
Fluent in English with oral presentation and training capabilities</li><li>
Able and willing to travel as needed, up to 30%</li><li>
Expertise in GCP and regulatory requirements.</li><li>
Strong leadership and team management skills.</li></ul></div><p></p>

Clinical Project Manager

Dana-Farber Cancer Institute

<b>Job Ref:</b><br>
46863
<br><br>
<b>Location:</b><br>
450 Brookline Ave, Boston, MA 02215
<br><br>
<b>Category:</b><br>
Clinical Research
<br><br>
<b>Employment Type:</b><br>
Full time
<br><br>
<b>Work Location:</b><br>
<b>Remote:</b> occasional time on campus
<br><br>
Overview
<br><br>
The Clinical Research Project Manager I is responsible for the day-to-day coordination and management of Cutaneous Oncology clinical trial activities, primarily focusing on multi-center, PI-initiated trials. They ensure trial and site startup coordination, train site research staff, handle regulatory submissions, track safety events, and communicate with regulatory authorities. Reporting to disease group managers and/or Clinical Trials Office (CTO) leadership the Clinical Research Project Manager I identifies project plan variances and develops contingency plans to maintain project milestones. They may also oversee operational and training aspects of the EPIC/OnCore application, working closely with faculty, staff, and stakeholders to develop infrastructure, procedures, and tracking systems for project management services. This role requires independent work under general supervision within their disease group or CTO, with a focus on ensuring compliance and efficient trial execution.
<br><br>
This position's work location is fully remote with occasional time on-campus in Boston, MA. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).
<br><br>
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
<br><br>
Responsibilities
<br><br>
<b>Day-to-Day Project Oversight:</b> Manage the daily operations of assigned clinical trials, ensuring efficient execution and adherence to timelines while maintaining compliance with clinical trial regulations. This involves monitoring budgets, resources, and coordinating with cross-functional teams to meet project milestones.
<br><b>Trial Master File (TMF) Development and Maintenance:</b> Develop and maintain the TMF, ensuring all essential documents are organized, accessible, and compliant with Good Clinical Practice (GCP) standards. Regular updates are conducted to ensure compliance with regulatory standards and institutional policies.
<br><b>Protocol and Consent Form Development:</b> Assist the Principal Investigator (PI) in developing protocols and consent forms for initial applications and amendments, ensuring they meet regulatory requirements and are easily understood by participants. This requires translating complex scientific concepts into clear, concise documents.
<br><b>Clinical Trial Phases Management:</b> Initiate, plan, and oversee the start-up, active, and close-out phases of clinical trials, particularly for PI-initiated and multi-center studies. Coordination with stakeholders, including site staff and external partners, ensures smooth transitions between phases and adherence to timelines.
<br><b>Case Report Form Design and Database Maintenance:</b> Design case report forms based on PI directives and maintains study-related databases, ensuring data integrity and compliance with clinical trial standards. Prepare protocol-related reports and data summaries to support ongoing research activities and decision-making.
<br><b>Administrative Support:</b> Schedule research team meetings and conference calls, facilitate mailings, and perform other project-related administrative tasks to ensure effective communication and coordination among team members and external collaborators.
<br><br>
Qualifications
<br><br>
Bachelor’s degree in a field relevant to clinical research required.
<br>Three (3) years of experience in clinical research or project management, ideally within multi-center oncology trials, with specific experience in managing clinical trial operations.
<br>Experience in an academic institution with a proven track record of success in the clinical research field is preferred, particularly in roles involving clinical trial coordination and management.
<br><br>
<b>KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b><br>
Basic understanding of clinical trial processes and regulatory requirements, including Good Clinical Practice (GCP) guidelines.
<br>Familiarity with trial management software and tools, such as EPIC and OnCore, for efficient trial coordination.
<br>Awareness of data management practices and documentation standards, with an emphasis on compliance and accuracy.
<br>Strong organizational and time management skills to handle multiple tasks efficiently, ensuring adherence to clinical trial timelines.
<br>Effective communication skills for interacting with research staff, stakeholders, and regulatory authorities.
<br>Basic problem-solving skills to address project-related issues, with the ability to anticipate and mitigate potential challenges.
<br>Ability to work independently under general supervision, while maintaining compliance with clinical trial protocols.
<br>Capability to learn and adapt to new procedures and technologies, including updates in clinical trial regulations.
<br>Competence in maintaining accurate records and documentation, ensuring compliance with regulatory standards.
<br>Understanding of ethical considerations and patient confidentiality in clinical trials.
<br>Ability to collaborate effectively with cross-functional teams and external partners to support trial objectives.
<br><br>
Pay Transparency Statement
<br><br>
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.
<br><br>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
<br><br>
<b>Salary range:</b> $76,911 - $85,295
<br><br>
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
<br><br>
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
<br><br>
EEOC Poster

Clinical Research Project Manager - Cutaneous

Cleveland Clinic

<p></p><div><div><p>Join Cleveland Clinic&rsquo;s Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.</p><p><br>
This role manages the full administrative and operational lifecycle of Phase I-IV clinical research trials. Acting as a central coordinator, the position ensures seamless communication and collaboration among investigators, sponsors, regulatory bodies, and internal teams. A critical part of the role is guiding physicians in protocol development and ensuring regulatory compliance, especially given that many clinicians lack in-depth regulatory knowledge. You interact with physicians and investigators, clinical trial sponsors, clinical research team members, regulatory bodies (IRB and FDA), other internal departments and external research sites.</p><p><br>
The position requires managing several concurrent studies (typically 4&ndash;5), which may vary in length from a few months to over a decade (especially for device trials).</p><p><br>
Responsibilities also include site selection, performance assessment, and recommending continuation or termination of site participation based on quality. The project manager plays a vital role in protocol review and site monitoring coordination. Experience in cardiovascular research (particularly within the HVTI network) is valuable, and international collaboration is part of the role, including work with physicians in Abu Dhabi.</p><p><b><br>
A caregiver in this position works full-time, from 8:00am&mdash;5:00pm.</b> <b>(M-F).</b></p><p></p><p>
A caregiver who excels in this role will:</p><ul><li><p>
Manage and coordinate a clinical trials team (external industry team members, statisticians, database programmers and researchers) responsible for data accumulation, input and analysis.</p></li><li><p>
Interact with the Finance and Legal departments to facilitate clinical trial budget, site budget and contract execution.</p></li><li><p>
Maintain professional relationships with Sponsor including frequent, open communication and associated documentation.</p></li><li><p>
Coordinate development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by Institutional Review Board (IRB), Sponsor and FDA.</p></li><li><p>
Collect and review regulatory documents from sites.</p></li><li><p>
Communicate with institutional and central IRBs, FDA and other parties regarding protocol subject and safety issues.</p></li><li><p>
Organize, coordinate, attend and participate in Investigator Meetings and training programs.</p></li><li><p>
Develop and maintain planned communication with sites (i.e., newsletters, study progress updates, telephone communication, supportive reinforcement of Sponsor communication, etc.).</p></li><li><p>
Analyze site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites.</p></li><li><p>
Assesse investigator and site performance.</p></li><li><p>
Lead initiative to improve quality and makes recommendation to discontinue site if necessary.</p></li><li><p>
May assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.</p></li><li><p>
Perform other duties as assigned.</p></li></ul><p></p><p>
Minimum qualifications for the ideal future caregiver include:</p><ul><li><p>
Bachelor's degree in nursing, general science, a health care discipline or computer science with programming emphasis</p></li><li><p>
3 years clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate or equivalent management experience in a related field</p></li><li><p>
OR Associate&rsquo;s Degree and 5 years of experience</p></li><li><p>
OR Master&rsquo;s Degree and 2 years of experience</p></li><li><p>
Excellent interpersonal, organizational and project management skills</p></li><li><p>
Substantial scientific and medical knowledge across relevant therapeutic areas</p></li><li><p>
Demonstrated ability to work with multiple software technologies</p></li><li><p>
Knowledge of FDA regulations, GCPs, and internal SOPs</p></li><li><p>
Knowledge of Code of Federal Regulations, ICH and GCP guidelines and their applications to clinical research trials</p></li><li><p>
Within 90 days of hire, must successfully complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic</p></li><li><p>
Demonstrated background/ability or working with clinical studies and clinical research team members at all levels</p></li></ul><p></p><p>
Preferred qualifications for the ideal future caregiver include:</p><ul><li><p>
Supervisor experience desirable</p></li><li><p>
Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification desirable</p></li></ul><p><br>
Our caregivers continue to create the best outcomes for our patients across each of our facilities. Click the link and see how we&rsquo;re dedicated to providing what matters most to you: https://jobs.clevelandclinic.org/benefits-2/</p><p></p><p><b>
Physical Requirements:</b></p><ul><li><p>
Requires full range of motion, manual and finger dexterity and eye-hand coordination.</p></li><li><p>
Requires standing and walking for extensive periods of time.</p></li><li><p>
Requires normal or corrected hearing and vision to normal range.</p></li></ul><p></p><p><b>
Personal Protective Equipment:</b></p><ul><li><p>
Follows standard precautions using personal protective equipment as required.</p></li></ul></div><p></p><div><p><b>
Pay Range</b></p><p></p><p>
Minimum Annual Salary: $63,250.00</p><p></p><p>
Maximum Annual Salary: $96,467.50</p><p>
The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate&rsquo;s actual compensation will be determined after taking factors into consideration such as the candidate&rsquo;s work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic&rsquo;s benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).</p></div></div>

Clinical Research Project Manager - HVTI Research & Registries

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><p><br>
Job Description</p><p>
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.</p><p></p><p><b>
Summarized Purpose:</b></p><p>
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. 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 independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.</p><p></p><p><b>
Key Responsibilities</b>:</p><ul><li>
Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.</li><li>
Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc&hellip;): ensure feasibility report are exhaustive, Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.</li><li>
Support and ensure that all specific EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial.</li><li>
Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)</li><li>
Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan</li><li>
Validate the final clinical study documents (such as study manual, monitoring plan &hellip;) prepared by the Clinical CRO.</li><li>
Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.</li><li>
Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.</li><li>
Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.</li><li>
May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.</li><li>
Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.</li><li>
In North America, where assigned to GPHS (Government &amp; Public Health Studies) projects, may have limited line management responsibilities</li></ul><p>
Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues</p><p><b>
Knowledge, Skills and Abilities</b>:</p><ul><li>
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). 1+ year of leadership responsibility</li><li>
MUST HAVE previous experience in both on site monitoring &amp; in a CTM role</li><li>
Rare Disease Experience is HIGHLY preferred</li><li>
Travel: 40-50% Travel; US Travel</li><li>
Previous On Site Monitoring Experience</li><li>
Advanced mentoring/leadership/supervisory skills</li><li>
Excellent clinical trials monitoring skills; ideally remote AND onsite experience</li><li>
Demonstrated understanding of or ability to learn the company&rsquo;s SOPs, WPDs, and relevant regulations(e.g. ICH/GCP, FDA guidelines)</li><li>
Strong organizational and negotiation skills</li><li>
Strong attention to detail</li><li>
Advanced written and oral communication skills</li><li>
Strong knowledge of English language and grammar</li><li>
Demonstrated use of computer to include data entry, archival and retrieval</li><li>
Ability to travel as needed</li><li>
Excellent team player with team building skills</li><li>
Excellent interpersonal and conflict resolution skills</li><li>
Advanced ability to utilize problem-solving techniques applicable to constantly changing environment</li><li>
Solid knowledge of medical/therapeutic areas and medical terminology</li></ul><p></p><p>
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.</p><p>
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.</p></div><p></p>

Senior Clinical Trial Manager, FSP

<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><p>
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.<br>
We have a vacancy for an ICF Medical Writing Project Manager based in a number of global locations.</p><p></p><p>
Our Medical Writing team is growing and we are looking for a Senior/ICF Medical Writing Project Manager in multiple locations in EMEA region.</p><p></p><p>
Discover Impactful Work:</p><p></p><p>
Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Informed Consent Forms (ICFs) and other critical documents, ensuring outstanding quality and compliance.</p><p></p><p>
A day in the Life:</p><ul><li><p>
Develop project timelines, standards, budgets, and forecasts.</p></li><li><p>
Collaborate with cross-functional teams to meet deliverables.</p></li><li><p>
Monitor timelines and provide status updates.</p></li><li><p>
Identify and resolve client management issues.</p></li><li><p>
Ensure compliance with quality processes.</p></li></ul><p></p><p>
Keys to Success:</p><ul><li><p>
Proven project management skills.</p></li><li><p>
Strong planning and organizational abilities.</p></li><li><p>
Excellent interpersonal and communication skills.</p></li><li><p>
Ability to work independently and under pressure.</p></li></ul><p></p><p>
Education</p><ul><li><p>
Prefer BS/BA in a scientific field with 5 years experience, or an advanced degree with 3 years experience.</p></li></ul><p></p><p>
Experience</p><ul><li><p>
Experience managing medical writing or clinical projects.</p></li><li><p>
Pharmaceutical/CRO industry experience preferred.</p></li><li><p>
Advantageous to have experience in regulatory and/or plain language medical writing.</p></li></ul><p></p><p>
Knowledge, Skills, Abilities</p><ul><li><p>
Solid project management, budgeting, and forecasting skills.</p></li><li><p>
Effective problem-solving and decision-making abilities.</p></li><li><p>
Proficient in global and regional regulatory guidelines.</p></li></ul><p></p><p>
Benefits</p><p></p><p>
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!</p><p></p><p><b>
What We Offer:</b></p><p>
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We&rsquo;ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.</p><p></p><p>
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.</p></div><p></p>

Senior/ICF Medical Writing Project Manager

IQVIA

<div><p><b>Job Overview</b><br>
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.<br>
<br>
<b>Home Based role that require Arabic language fluency.
</b></p><p></p><p><b>Essential Functions</b></p><ul><li><p>
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.</p></li><li><p>
Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.</p></li><li><p>
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.</p></li><li><p>
Distribute completed documents to sites and internal project team members.</p></li><li><p>
Prepare site regulatory documents, reviewing for completeness and accuracy.</p></li><li><p>
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.</p></li><li><p>
Review and provide feedback to management on site performance metrics.</p></li><li><p>
Review, establish and agree on project planning and project timelines.</p></li><li><p>
Ensure monitoring measures are in place and implement contingency plan as needed.</p></li><li><p>
Inform team members of completion of regulatory and contractual documents for individual sites.</p></li><li><p>
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.</p></li><li><p>
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.</p></li><li><p>
Perform quality control of documents provided by sites.</p></li><li><p>
May have direct contact with sponsors on specific initiatives.</p></li></ul><p></p><p><b>
Qualifications</b><br>
<b>Bachelor&rsquo;s Degree in life sciences or a related field and 3 years&rsquo; clinical research or other relevant experience; or equivalent combination of education, training and experience.</b></p><ul><li><p>
In-depth knowledge of clinical systems, procedures, and corporate standards.</p></li><li><p>
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.</p></li><li><p>
Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company&rsquo;s Corporate Standards.</p></li><li><p>
Understanding of regulated clinical trial environment and knowledge of drug development process.</p></li></ul><p></p><p>
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</p></div>

Regulatory and Start Up Specialist

ICON plc

<div>Manager, Clinical Operations<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 Manager, Clinical Operations to join our diverse and dynamic team. As a Manager, Clinical Operations at ICON, you will play a pivotal role in overseeing the execution of clinical trials, ensuring that they are conducted efficiently, on time, and in compliance with regulatory requirements. You will contribute to the advancement of innovative therapies through strategic leadership in operational planning and management of clinical study teams.</div><div>
What You Will Be Doing:</div><div></div><ul><li>
Leading the operational planning and execution of clinical trials, ensuring adherence to protocols and timelines.</li><li>
Engaging with cross-functional teams to optimize trial design and enhance operational efficiency throughout the clinical development process.</li><li>
Monitoring trial progress and performance metrics, providing insights to inform decision-making and drive continuous improvement.</li><li>
Mentoring and developing junior staff, fostering a culture of collaboration and excellence within the team.</li><li>
Building strong relationships with internal and external stakeholders to facilitate smooth communication across clinical operations.</li></ul><div>
Your Profile:</div><div></div><ul><li>
Advanced degree in a relevant field such as life sciences, nursing, or a related discipline.</li><li>
Extensive experience in managing clinical operations, with a solid understanding of regulatory requirements and industry standards.</li><li>
Strong leadership skills with the ability to motivate and manage teams effectively in a dynamic environment.</li><li>
Proficiency in project management tools and methodologies, with a keen focus on optimizing processes.</li><li>
Excellent communication and interpersonal skills, with a proven ability to influence stakeholders and drive successful outcomes.</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>

Manager Clinical Operations

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