Senior Clinical Project Manager

Senior Clinical Project Manager

Ipsen Pharma

Paris or London

About the Role

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

The CPM has responsibility for planning, initiation, conduct 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 then this is undertaking the activities personally and coordinating the deliverables of the internal CFT.

Key Responsibilities

Clinical Research Leadership (Senior Clinical Project Manager)

• Work with internal stakeholders and Cross Functional Team to ensure excellence in execution of all evidence generation activities.
• Provide internal consultancy and thought leadership with regards to the conduct of clinical research.
• Design study synopses and develop research protocols aligned with integrated evidence generation plans (IEGP) that will support the study through Ipsen approval pathways.

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.
• Own preparation of the project budget including financial and clinical supply forecasting.
• Develop the study timelines planning for critical events and milestones as agreed by the Cross Functional Team.

Initiation of the study

• Lead the SP selection process.
• Co-ordinate completion of the study Integrated Oversight Plan (IOP) prior to initiation of the study defining and agreeing KPIs/QTLs/Performance indicators with SPs and the Cross Functional Team.
• Oversee SP performance and creation of documents required for the execution of the study.

Study Conduct

• Coordinate the CFT (internal and SPs) overseeing the progress of the study and SP’s performance to ensure timely on budget delivery.
• Monitor execution and delivery of KPIs/QTLs/Performance indicators as agreed in the IOP.

Study Completion

• Coordinate the preparation, the review and the 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.

Ability to travel as required with the needs of the role, up to approximately 25% of the time.

Qualifications

• Strong project clinical operations experience.
• Significant and relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs.
• Significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs.
• Experience and know-how in Oncology or in Rare Diseases or in Neurosciences.
• Proven track record of delivery of projects to time, budget and quality.
• Extensive track-record of interactions with country Medical Affairs Staff.
• Experience of managing and developing relationships with Service Providers.
• Fluency in English.