Clinical Project (Study) Manager

Clinical Project (Study) Manager

Clinical Project Manager

Clinical project manager, late phase, senior clinical researcher, Monitoring, coordination, documentation, quality, auditing, senior research associate, CPM, CSM, Study Manager, Interim, Freelance

Are you looking for an exciting new challenging at a pharmaceutical company? Do you have the necessary skills and experience to hit the ground running? This could be a great opportunity for you. My client is looking for a Clinical Project Manager with broad experience and preferably specialised in the area of Oncology, Neurology or Cardiology (Medical device studies). This is an interim assignment and will be for the duration of 8 months in Antwerp. You'll be working on multiple studies and will be part of a small team.

The ideal candidate
* Considerable experience in clinical trial management, preferably in the Pharmaceutical industry - Requires clinical research operational and procedural knowledge
* Bachelor level education in Life Sciences or related discipline, and/or extensive work experience in a similar capacity
* 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.
* The role may require travelling between different locations.

The Role
* Set up and monitor clinical trials within Belgium
* 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 at (see below)

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.