Clinical Project Manager

Clinical Project Manager

Company:
Ipsen Biopharmaceuticals Inc.

• Company Sponsored Studies (CSS)
• Prepare the study.
• Set up and lead the Cross‑Functional Team (CFT), overseeing study design and kick‑off activities.
• Initiate high‑level feasibility and continuously monitor how changes to the study design affect feasibility during preparation and development of the protocol.
• Develop study timelines and plan for critical events and milestones as agreed by the CFT.
• Drive excellence in execution and adherence to the project plan through the application of project‑management best practices.
• Oversee SP performance and creation of documents required for study execution.
• Identify and select investigator sites in collaboration with the Medical Asset Lead, SP and MSL team.
• Coordinate the set‑up of the eTMF (Trial Master File).
• Ensure that the CFT and investigator sites are appropriately trained (including creation and approval of training materials and coordination of investigator meetings).
• Complete posting of the study on external registries (clinical trials.gov, etc.) in partnership with the Global Regulatory team to ensure compliance with transparency requirements.
• Ensure that all necessary regulatory, ethical, IRB and governance approvals are in place prior to the commencement of recruitment at an investigator site.
• Coordinate the CFT (internal and SPs), oversee study progress and SP performance to ensure timely, on‑budget delivery.
• Proactively address deviations and non‑compliances affecting patient rights, safety, protocol adherence or ethical conduct.
• Provide end‑to‑end oversight of data to ensure delivery to the defined protocol, timelines and quality, and timely execution of data deliverables.
• Provide and present regular reports on study progress, including site performance, data quality and resource needs.
• Ensure the CTMS is updated and that data in SMD is submission‑ready; be accountable for eTMF inspection readiness.
• Coordinate the preparation, review and submission of the CSR with Medical Writing.
• Ensure the finalization and archiving of the eTMF.
• Post study results to required registries and complete all regulatory reporting requirements of study results and end‑of‑study summaries.
• Ensure all close‑out activities are completed per study plan and relevant SOPs.

• 5+ years of relevant experience in pharmaceutical drug development, including project management of US Phase I‑IV studies, or significant experience in RWE/HEOR, non‑interventional studies and Investigator‑Sponsored Studies (ISS).
• Proven track record of delivering projects on time, budget and quality.
• Extensive experience interacting with country Medical Affairs staff; deep knowledge of Good Clinical Practice (GCP) for CPMs managing interventional CSS and non‑GCP data regeneration regulations for CPMs managing NIS.
• Experience working with multidisciplinary groups and ability to work within a team environment.
• Experience managing and developing relationships with Service Providers.
• Excellent organizational and management skills.
• Excellent verbal and written communication skills.
• Experienced with Microsoft Office applications for creating and maintaining project timelines, budgets and reports.

• Experience in Oncology, Rare Diseases or Neurosciences.

• Bachelor’s degree in life sciences required.
• Master’s degree or equivalent preferred.

• Fluent in English.

The annual base salary range for this position is $112,500-$165,000.

We offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short‑ and long‑term disability insurance, and flexible spending accounts. Additionally, we provide parental leave, paid time off, a discretionary winter shutdown, well‑being allowance, commuter benefits and more.

Ipsen Biopharmaceuticals, Inc. is an equal‑opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

We conduct background screening, reference checks, and drug testing as part of our pre‑employment screening process.

We strictly prohibit unlawful discrimination and affirm our commitment to creating a workplace where everyone feels heard, valued, and supported.