Clinical Trials Integration Project Manager

Geplaatst op
2 tot 6 maanden
Op locatie


Your responsibilities

You will be primarily responsible for the following activities

  • TMF integration: Development and maintenance of PM methodology and tools to ensure coordination and oversight of the TMF related integration activities.

This will include

 - Support the Head TMF, Regional Heads and LOCs for activities related to the Local TMF transfer to a vendor: Project Management, connections between stakeholders to ensure questions are answered.
 - Ensure updates of TMF transfer process are clearly cascaded to the team.
 - Support operations team and be the day-to-day contact for the LOC.
 - Ensure aligment with the vendor Project Manager.
 - Ensure tracking of progress, …

  • SOP transition coordination: Overall support and Project Management to ensure cross-functional coordination and alignment in the SOP updates process to ensure (ensure we keep control an governance on all the updates needed and involvement of the right stakeholders, manage progress tracking and communication with CEG Leadership).

  • End-to-end Clinical Trials RACI: Project management and coordination of a cross-functional team of experts to review the RACI to ensure it reflects the new R&D operating model. Work with the team to identify area of improvement to make this process leaner and propose solution. Ensure progress report and communication.

Your profile

  • University level.

  • Experience in the pharmaceutical sector is an asset.

  • Appropriate Project Management (PM) qualification and experience is mandatory.

  • Understanding of Clinical development and Operations environment.

  • Understanding of Clinical Documentation Management processes and systems.

  • Fluent in english.

  • An aptitude for process management.

  • Analytical, logical thought process with strong organisation/management skills.

  • Understanding of project management software (ideally MS Project).

  • Effective time management, ability to clearly identify priorities and manage multiple tasks.

  • Strong interpersonal and influencing skills, communication skills.

  • Good presentation skills.

  • Very Flexible (adapting to changes within a project, i.e changes of priorities, increase/decrease of workload).

  • Positive attitude.

  • Customer minded.

  • Can travel up to 20% of the time.

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