Global Clinical Project Manager
il y a 1 jour
**Title**:
Global clinical project manager
**Company**:
Ipsen Innovation (SAS)
Oversee and drive all aspects of the assigned global international clinical study(ies) (Phase I to III) outsourced to a CRO in respect of planning/timelines, quality, budget and defined goals
Drive execution and report activities in conjunction with Clinical Development Program Directors (CDPDs), Medical Dev. Directors (MDDs), and other Ipsen team members
Endorse project plan developed by the CRO in accordance with study objectives and Ipsen requirements in terms of team responsibility, risk mitigation plan, escalation process, communication plan...
Ensure the Global clinical studies are managed according to Good Clinical Practice (GCP), local regulations, guidelines and SOPs in the required standard of quality
Communicate and share the progress of the project, and work effectively as a Team
Manage and lead the cross-functional Clinical Team and Contract Research Organization (CRO) in collaboration with the CDPDs and Ipsen team members responsible of the study
Main responsibilities and tasks
Ensure clinical team management and communication
Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget
Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members (Clinical Development, Medical development, Biometry, Pharmacovigilance, Finance controlling, CMC ) and CROs
Establish and maintain excellent professional relationships with Services Providers / CROs, clinical study team through regular communication, between company, investigators and experts in conjunction with Therapeutic Area (TA) / Medical Dev. Director (MDD) and other relevant Ipsen team members
Lead clinical project processes
Lead cross-functional clinical project teams focused on conduct of assigned projects
Interact with CDPD to define strategic direction
Review status reports provided by Service Provider/CRO and highlight issues to facilitate decision making
Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to CSR, in respect of GCPs and relevant SOPs
Key accountabilities and activities
Develop, manage, and execute assigned projects by:
Set-up study team before Services Provider / CRO on board
Contribute to study protocol development including study concept where applicable
Propose and control planning and study timelines in collaboration with all other Ipsen supportive functions/CRO
Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO
Participate in the selection of Services Providers /CROs and other external vendors in collaboration with purchasing department, study team and Corporate Legal Affairs
Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative - financial management of the clinical trial including budget planning and preparation of quarterly reports
Ensure appropriate oversight of Services Providers /CRO(s) and other external vendors activities within full outsourcing business model and develop the oversight manual in accordance with the services providers R&R document
Review final draft and approve major study documents as described in the Services Providers /CROs R&R document (e.g. oversight manual, communication plan, project plan, instruction manuals.)
Supervise country feasibility and site selection processes in collaboration with CDPD, TA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high quality investigators and study sites
Support the CTA assigned to the study for: insurance certificate, contracts signature process, set-up update and archive of the Trial Master File (eTMF), transparency and local requirements reporting as per legal and Ipsen requirements, update of reporting tools (study trackers, Hermes, ) and alert if required; drive billing and forecast
Work with the CRO to develop and approve a recruitment strategy and communication tools (e.g. Newsletter ) to increase study awareness, patient recruitment and retention in the study
Ensure through study team management that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities in conjunction with the Regulatory, Pharmacovigilance (GPS), Data Management and Statistics Departments
Participate in meetings lead by CRO (e.g. Inv. & CRA meeting, Study team meeting, Clinical Data Review), internal meeting - Review meeting minutes and ensure with CRO Project Manager that issues are proactively identified, communicated and resolved in a timely manner
Ensure timely and accurate completion of project milestones, st
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