Clinical Project Manager

Title:

Clinical Project Manager

Company:

Ipsen Biopharmaceuticals Inc.

Job Description:

Clinical Project Manager (hybrid)

Summary / purpose of the position

The Clinical Project Manager (CPM) is a Project Leader with the end-to-end accountability for the successful execution of US Evidence Generation activities including but not limited to interventional and non-interventional Company Sponsored Studies (CSS), Investigator-Sponsored Studies (ISS), Research with Secondary Use Data (SUD) and other assigned medical affairs projects falling within the remit of US Clinical Operations.

The CPM has responsibility for planning, initiating, conducting and reporting for all assigned evidence generation projects ensuring completion to budget and within timelines according to the relevant GXP regulations, external guidelines, SOPs and quality standards. Where activities are outsourced, this means oversight of the Service Provider (SP) and co-ordination of internal cross functional team (CFT). If in house, this is undertaking the activities personally and coordinating the deliverables of the internal CFT. This role may also support the US site start-up activities of Company Sponsored Studies (CSS) managed by Global Medical Affairs (GMA). These activities include US site contract negotiation, Medical Review Committee (MRC) submissions of GMA CSS PSV/SIV slide decks, study newsletters and any other clinical trial recruitment and retention materials.

Main responsibilities / job expectations

Responsibilities will include, but are not limited to the following:

Company Sponsored Studies (CSS)

Preparation of the study:

• Set up and lead the study 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 the preparation and development of the study protocol.

• Develop the study timelines planning for critical events and milestones as agreed by the Cross-Functional Team.

• Drive excellence in execution and adherence to the project plan through the application of project management best practices.

Initiation of the study:

• Oversee SP performance and creation of documents required for the execution of the study

• 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 study CFT and investigator sites are appropriately trained. (e.g.: Oversight of or creation and approval of investigator training materials, completion and co-ordination of investigator’s meetings)

• Complete posting of the study on external registries (clinicaltrials.gov etc.) in partnership with the Global Regulatory team to ensure compliance with Ipsen transparency requirements and regulatory commitments.

• Ensure (or Oversight of) that all necessary regulatory, ethical, IRB and governance approvals are in place prior to the commencement of recruitment at an investigator site.

Study Conduct:

• Coordinate the CFT (internal and SPs), overseeing the progress of the study and SP’s performance to ensure timely on-budget delivery.

• Proactively escalate deviations and non-compliances affecting the rights, well-being, and safety of patients, adherence to the protocol or the ethical conduct of the study.

• Provide end-to-end oversight of the data to ensure delivery to a defined protocol, timelines, and quality, timely execution of data deliverables, and subsequent delivery of excellence in execution.

• Provide and present regular reports on study progress, including site performance, data quality, and resource needs.

• Ensure that the CTMS is updated and that data in SMD is submission-ready.

• Accountable for eTMF inspection readiness.

Study Completion:

• Coordinate the preparation,  review, and submission of the CSR with Medical Writing.

• Ensure the finalization and archiving of the eTMF.

• Ensure that the study results are posted to the required registries.

• All necessary regulatory reporting requirements of the study results and end of study summaries are completed.

• Ensure all the close-out activities a