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Clinical Project Manager

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Biotech, Biotechnology, Life Sciences - Liège

Founded in 2014, PDC * line Pharma is a Belgian-French biotech company that is developing a novel class of off-the-shelf active cancer immunotherapies. The technology developed by this spin-off of the French Blood Bank (Etablissement Français du Sang, EFS) can be applied to any type of cancer.

After a first-in-human feasibility clinical study in melanoma, PDC*line Pharma is focusing on new candidates to fight other cancers, including lung cancer, with a new clinical trial underway. The company currently employs more than 20 people and with an experienced management team. So far, the company has raised more than €37 million in capital and subsidies and repayable advances.

In order to strengthen the team in Liège (Belgium), we are actively looking for a:

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Clinical Project Manager

Responsibilities :

As a Clinical Project Manager and reporting directly to the Clinical Operations Manager, you play an important role in the overall management of the clinical studies.

Your main responsibilities are :
  • Manage external CROs to ensure protocol, procedures, GCP and regulations compliance.
  • Collaborate with the internal departments involved in the trials.
  • Take part in the writing of the study documents and in the preparation of regulatory files.
  • Set up and organize DSMB as required.
  • Develop clinical quality activities within the company (SOPs writing, vendors/sites audit…)
  • Participate in financial activities such as contracts follow-up, CROs invoices and sites fees management.
  • Manage TMF compliance and maintenance.
  • Participate in additional tasks such as sites identification/partners/vendors for further clinical development.
Profile:
  • You hold a master’s degree in Life Sciences, or equivalent.
  • You have at least 5 to 10 years of experience in clinical trial management in a Biotech, a CRO or a pharmaceutical company.
  • You have experience in clinical studies, preferably in oncology.
  • Experience in early phase, clinical quality and/or budget management is an asset.
  • You are hands-on and able to work autonomously with a dynamic team spirit.
  • You have strong analytical skills with excellent attention to detail.
  • You have excellent coordination and communication skills.
Offer:
  • A diversified position with a lot of autonomy and contact with other internal departments.
  • The opportunity to join a human-sized, dynamic and challenging environment.
  • A permanent contract and an attractive salary package in line with your experience.
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