For one of our clients in the region of Leuven we are looking for an experienced Clinical Project Manager, preferrably with international experience.
In case you have the necessary experience and are interested in working in the EMEA headquarters of a leading medical devices company, then don't hesitate to reach out to us!
As Clinical Project Manager you are the driver of the Clinical Research team in the coordination of the project. The responsibilities of the Clinical Project Manager include the setup and follow-up of clinical studies assigned to your responsibility. The Clinical Project Manager is the main contact person for all parties involved.
Management of Clinical Trials
- Management of the clinical trials assigned to his/her responsibility
- Plan, establish and guard study time-lines, required resources and protocol specific milestones
- Assign study team in collaboration with Head of Clinical affairs
- Participate in selection of research locations & CROs
- Responsible for the set-up and maintenance of the administrative structure of the project(s)
- Coordinate with the project team:
- Preparation of the materials for clinical trials (Investigational plan, Investigators brochure, Patient information, monitoring and study guidelines ...)
- Preparation of files for the submission to Ethics committees, Competent Authorities and other bodies if needed
- Preparation of files for Clinical trial insurance
- Follow-up of agreements with hospitals and investigators
- Establish appropriate committees (CEC, DMC) and organize meetings according to schedule
- Coordination of payments to clinical sites according to contract milestones
- Follow-up of enrolment and milestone follow-ups and develop actions to optimize it
- Writing monitoring Manual
- Ensure proper clinical trial monitoring
- Regular communication with the study sites and CRO
- Regular reporting of project status to management and business units
General administration related to the clinical trials
- Oversee clinical trial documentation filing and ensure compliance with regulations
- Closely follow relevant regulatory requirements related to conduct of clinical trials in different countries and regions
- SOP preparation and update
- Ensure project documents are compliant with regulations and internal SOPs
Clinical data analysis
- Writing clinical trial reports
- Coordinate with Medical&Scientific team to ensure data availability on specified milestones
- Act as a representative of the company.
- Interact closely with administrative departments and commercial organisation of the company.
- Assume all other responsibilities and authorities this function may require regarding new opportunities.
- Reporting to the Clinical Program Manager(s) for the assigned therapeutic areas.
- Master Life sciences degree or equivalent by experience
- Minimum 5 years experience in Clinical trials
- Good knowledge of project management and regulatory requirements
- Well-developed computer skills, communication skills, and presentation skills
- Analytical with well-developed scientific rigor
- Strong problem solving skills
- Team player, working with others to reach results/resolution
- Travel experience
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