Senior Clinical Project Manager

Cookie Notice
*
* Title:

** Senior Clinical Project Manager
** Company:
** Ipsen Biopharmaceuticals Inc.
** About Ipsen:
** Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:
Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.

We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at and follow our latest news on and .
*
* Job Description:

**** Clinical Research Leadership (Senior Clinical Project Manager)
*** To work with internal stakeholders and Cross Functional Team to ensure excellence in execution of all evidence generation activities.
* To provide internal consultancy and thought leadership with regards to the conduct of clinical research
* To contribute to, and provide insight on, the design and development of study synopses and research protocols aligned with Integrated Evidence Generation Plans (IEGP), to ensure they are operationally viable, in order to  support the study through Ipsen approval pathways.
* To participate in consultations with key opinion leaders and external stakeholders, to develop studies relevant to patients and the clinical community.
** 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.
* Drive excellence in execution and adherence to the project plan through application of project management best practices.
* Liaise with Global Patients Affairs to embed patient centricity into study conduct and the design of Ipsen evidence generation activities.
* Maintain awareness of digital opportunities through collaborative work with the Data & Insights Generation and Strategy (DIGS) and data strategy teams
* Establish close working relationships with Lead Medical Experts, Global Regulatory Affairs and Global Pharmacovigilance to support the submission and approval of PASS/PAES protocols to regulatory bodies such as EMA’s PRAC, the FDA, regional and local regulatory authorities.
** Initiation of the study
*** Lead the SP selection process (RFP creation, bid defense, contracting) and in collaboration with the CFT, Global Procurement and Corporate Legal Affairs.
* Co-ordinate completion of the study document and plans, defining and agreeing KPIs/QTLs/Performance indicators with SPs and the Cross Functional Team.
* Oversee SP performance and creation of relevant SP documents, required for the execution of the study.
* Identify and select investigator sites in collaboration with the Medical Asset Lead, SP and Ipsen Affiliates.
* Coordinate the set-up of the eTMF (Trial Master File) in collaboration with the CTA assigned to the study.
* 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).
* Ensure posting of the study on external registries (clinical trials.gov etc.) in compliance with Ipsen transparency requirements and regulatory commitments.
* Ensure (or oversight of) all necessary regulatory, ethical, IRB and governance approvals are in place prior to commencement of recruitment at an investigator site.
**…