Clinical Project Manager

For one of our clients we are urgently looking for an experienced Clinical Project Manager.

  • Do you have several years of experience as Clinical Project Manager?
  • Can you take the lead in global programs with regional PM's?
  • Are you available soon?

Then you might be the perfect match! We can also collaborate with freelance PM's.

Job Description 

The Project Manager provides leadership to a cross-functional study team in the execution of the clinical research projects. He/ she contributes in the initial study planning, setup and conduct of the project until final reporting phase.  This in accordance with the agreed budgets, timelines and company procedures and standards.  ​

Responsibilities 

You are responsible for: 

  • Planning of budget, resources and timelines for allocated studies
  • Initiation and participation in Process Improvement initiatives
  • Project accountability from initial planning, setup and study conduct until final reporting phase within agreed budget, timelines and with high quality (comply with company processes, ICH-GCP and applicable regulations and guidelines)
  • Vendor management: from initiation and coordination of the vendor selection process to being the contact person for vendors and making sure the study plans, timelines and budget are respected
  • Coordination of study document creation (Clinical Study Protocol, DSMB charter, Informed Consent Form, Clinical Study Report,…)
  • Review and/or approval of study documents (Monitoring Plan, TMF plan, Safety Plan, eCRF, a.o.)
  • Manage the appropriate filing and archiving of TMF - Internal single point of contact for assigned clinical studies, close interaction with functional experts involved in the clinical study (Medical Monitor, ClinPharm/PD lead, DM, Stat, CMC,…)
  • Organisation of cross-functional Internal Clinical Study Meetings as well as vendor meetings on a regular basis.
  • Follow-up with the Quality Monitor and follow-up on audit reports & CAPA set-up and resolution
Profile 
  • Demonstrated capability and experience as Clinical Project Manager in a pharmaceutical or biotech company 
  • Master's degree or PhD in life sciences, equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis.
  • Fluent in English (written and spoken). Any other language is an asset.
  • Good knowledge of ICH/GCP
  • Experience with vendor management / CRO oversight is an asset
  • Strong problem-solving and leadership skills.
  • Ability to prioritize and delegate.
  • Stress resistant and a strong team player with the ability to work independently without supervision.
  • Willing to travel (domestic and international) as needed.
Contact Information 

Nele Daems
(nele.daems@valesta.com)
015 21 11 04

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