International Clinical Project Manager

11 Sep 2018
25 Sep 2018
Contract Type
ProClinical is seeking an International Clinical Project Manager for a clinical stage biopharmaceutical company to be based in Belgium on a permanent basis. The International Clinical Project Manager Manage all activities within Clinical Operations related to 1 or more clinical trial(s), including clinical study timelines, budget, and quality from Study synopsis until Clinical Study Report. He/she coordinates and leads the activities of different Study Team members.

Job Responsibilties:

* Responsible for the operational aspects during the planning, start-up, conduct and close-out phase of the given trial(s) while ensuring the quality and the integrity of the data (e.g. in line with GCP/ICH guidelines) and adhering to the agreed project timelines and bud
* First point of contact for Clinical Operations-related questions for the given trial(s).
* Provide regular updates on trial evolution to the project teams and manager and escalate any significant issues which may have an immediate impact on patient safety or conduct of the study, timelines, budget and/or data quality.
* Contribute to timely development and/or review of trial-specific documentation (e.g., Protocol, Protocol amendments, Risk Management Plan, trial-related vendor documents. .).
* Ensure the timely selection and qualification of CRO' s and vendors, their training and management throughout the
* Organize Kick-off Meetings, Investigators meeting and managing the CRO's output and responsibility
* Operational implementation of trial protocol, including coordination of trial-related activities with both internal and external (CRO, central/referral labs) parties.
* Work in close relation with Clinical Trial Assistant(s).
* Contribute in process improvement activities within Clinical Operations

Skills and Requirements:

* At least 5 years of experience with international clinical operations in Pharma, Biotech or CRO (Phase 3 experience is a must)).
* A medical or paramedical (e.g. phannacy, biology, veterinary) degree.
* Excellent knowledge ofICH, European directives and FDA guidelines related to GCP, experienced with adhering to SOPs and guidelines regarding the conduct of clinical trials
* Team
* Project Management and organizational skills.
* Good Communication
* Flexible, conflict handling and problem-solving skills, sense of innovation
* Being accountable: exercising judgement/impact of decisions/consequence of error.
* Able to manage multiple and varied tasks and prioritize workload with attention to
* Good knowledge of written and spoken
* Knowledge of and experience with basic computer programs; experience with MS Project is an
* Is willing and capable to go the extra mile if needed

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lewis Davis on +44 203 8718 095 or upload your CV on our website -
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


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