Clinical Project Manager (Maastricht)

Clinical Project Manager

Clinical project manager, late phase, senior clinical researcher, Monitoring, coordination, documentation, quality, auditing, senior research associate

Position for Clinical Project Manager with a leading global pharmaceutical company, based in the south of the Netherlands. My client is a leading medical device company, looking to expand their team with a talented CPM.

The ideal candidate

* Considerable experience in clinical trial management, preferably in the Pharma/Medical device companies. Requires clinical research operational and procedural knowledge
* Must be flexible and have experience managing global or regional teams in a virtual environment
* Proven track record in successfully managing trials from start-up to database lock
* Strong leadership and delegation skills, and proven ability to foster team cohesiveness and productivity
* Excellent communication skills in English, both verbal and written. Speaking Dutch is a major bonus.
* The role may require travelling between different locations.

The Role

* Set up and monitor clinical trials within the Netherlands
* Create and update study-specific documents such as monitoring guidelines, informed consent forms, IMP related documentation, blinding plan, country and site feasibility related documents.
* Provide input into cross functional documents such as safety related documents, protocol deviations and issue escalation processes, external service provider oversight plan, filing and archiving plans
* Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes.
* Prepare and conduct health authority inspections and internal QA audits. Ensure that the SMT operates in a constant state of inspection-readiness.
* Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.

If you think you meet the criteria for this role, please apply to this post or forward your CV to me directly.

Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.