Senior Global Clinical Project Manager H/F

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

• Patient-Focused : The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.

• Employee Care : We care for our employees, who are the ambassadors making a real difference.

• Bold Leadershi p: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.

• Growth Opportunities : We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role

The Senior Global 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 Senior Global 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 international programs

• Significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs

• Strong experience in studies set up in different countries

• 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.

If you feel that this could be the right next step for you, we would be delighted to engage with your application.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.