Senior Clinical Project Manager

Title:

Senior Clinical Project Manager

Company:

Ipsen Bioscience, Inc.

Job Description:

Job title:  Sr. Clinical Project Manager

Department:  Clinical Development Operations, R&D

Line Manager: (Senior) Director /Clinical Program Director (CPD)

Location of the role:  UK (London) or France (Les Ulis) or USA (Cambridge)

Purpose of the position

• Sr. Clinical Project Manager(CPM) is accountable for the delivery of assigned clinical study on-time, within budget and  quality.  The CPM has full ownership within the clinical study team and as such will be leading and partnering with medical/clinical development, medical writing, data management, biostatistics, PV on the protocol and other study activities and ensure alignment with the asset teams and strategy.

• Provides leadership and guidance to the cross-functional clinical study team
• He/she is responsible for the external and internal stakeholder management in outsourcing/CRO model and an asset centric internal environment
• He/she will partner cross-functionally with purchasing and finance to drive RFP process and select appropriate partners for study(ies) in scope and manage and drive cross-functional and external/CRO teams to ensure full roll-out and timely execution of the study project plans according to the outlined strategy, scope and following the ICH/ GCP guidelines and Ipsen/CRO SOPs
• Sr. CPM could manage a complex Ph2/3 program or multiple studies at various stages of conduct (e.g.,Global Ph1 & Ph2/Ph3 study at the same time or a very complex Ph2/3 global study)

Main responsibilities and tasks

• Contribute to study protocol development including study concept,  investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate, where applicable
• Works closely with the CPD/Sr. CPD and cross-functional team members to develop and outline study plans, timelines and costs
• Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider
• Lead the selection of Services Providers (SPs) and other external vendors in collaboration with purchasing department, cross-functional study team, finance controller and Legal Affairs. Outline the assumptions document for the RFI/ RFP template, participate and drive the BID defense meetings and track responses to the questions. Work closely with the CPD/Sr. CPD and clinical study team to select the final CRO, finalize the SOW and budgets for the study. Ensure that the strategy outlined by the CRO is aligned with the asset/clinical strategy
• Accountable for the development, management and tracking of trial budget working closely with the finance and SP representative. Ensure that the clinical study stays on-track within the budget approved at governance. Tracks the changer orders closely
• Monitors resource utilization over the study life cycle
• Ensure appropriate oversight of Services Providers and other external vendors activities and develop the oversight plan  in accordance with Ipsen SOP ,the operational assumptions and scope of work of the SP contract(s)  
• Review final draft and approve all study plans, documents per applicable SOPs (e.g. oversight manual, communication plan, project plan, Vendor manuals, instruction manuals, monitoring plans, Medical monitoring plan, DM plan, TMF plan etc….) Facilitates reviews and maintenance of these critical plans with cross-functional team members

• Leads country feasibility and site selection processes in collaboration with Sr CPD/CPD, Medics and CRO. Seeks input where necessary from Ipsen Affiliates, to identify high quality investigators and study sites
  • Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs
  • Provides oversight to study start up, site contract/budget negotiations and site activation plans to ensure we stay on track to the projected study start-up timelines

• Provides support and oversee the activities of the Clinical Trial Associate (CTA) and Clinical Monitoring Lead (CML) assigned to the study per SOPs and job descriptions
• Works with the SP, Patient Affairs office, and digital team as appropriate to develop and approve a recruitment strategy and communication tools (e.g. Newsletter…) to increase study awareness, patient rec