Clinical Supply Project Coordinator

Job description

The Clinical Supply Project Coordinator is accountable for the coordination and implementation of the sponsor name change activity linked to IMP supply.

Responsibilities
  • In alignment with the sponsor name change implementation deadline and the IMP production plan provided by the master planner, build the implementation plan for Packaging Operations
  • Collect input from Regulatory department regarding the protocol amendment timelines and planned submission dates per country and incorporate these information in the implementation plan
  • Provide monthly updates per study and share visibility on the progress to the Clinical, Regulatory, Legal and Clinical Trial Supplies Departments
  • Follow up on all activities defined in the change control for this project
  • Proactively identify and highlight issues to the key stakeholders

Project and Stakeholder Management:

  • Uses project management techniques to manage effectively and efficiently the sponsor name change project for all impacted studies
  • Creates and maintains project plans, defining and achieving through the lead of crossfunctional teams the planned milestones regarding the activities including packaging, labeling, distribution and other supply systems
  • Secures optimal transfer of information
  • Drives strong partnership with stakeholders (CTS functions, Clinical Team, Global Distribution and Logistics (GDL), QA, Legal, Regulatory), participating/leading all required meetings as a liaison for CTS
Profile
  • Supply Chain Expertise: understands key supply chain processes and can balance cost and service to patients, including advanced understanding of the regulatory and GxPs requirements for IMP's as well as clinical trial distribution particularities
  • Augmented Analytics: is able to build queries and summarize data
  • Planning and Orchestrating Projects: applies project management techniques in day to day activities
Our offer
  • An attractive salary in line with your experience and skills
  • Fringe benefits including a medical insurance, pension plan and a care plan
  • A supporting environment
  • Respect for the life-work balance
  • Career planning
  • A focus on professional and personal growth through training and coaching
  • Room for personal engagement to help shape our company's future
Location
South of Brussels
Contact person

Rafael Hoebrechts

Personal profile
Attachments
PDF, DOC, DOCKX (5MB)
Contact details
Tim
Janssen
Managing Partner

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 487 10 61 46
tim.janssen@fern-valley.com