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:
Clinical Project Manager
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.
- 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.
- 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.