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International Clinical Project Manager

31.07.2019 REF: O190075 East Flanders

Organization

Local Affiliate of a Clinical Services Company Specialized in Medical Devices

Description of the Position

Under the direction of the Associate Director, Clinical Operations, the Senior Clinical Project Manager has responsibility for the comprehensive management of clinical studies and communication with study sites and sponsors. Occasional travel may be required. The Clinical Project Manager may also participate in the development of SOPs, and internal monitoring processes.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

- Ability to execute and manage all aspects of multi-center global clinical trials independently from concept to close-out within designated project budgets and timelines
- Develop clear and measurable project management plans and establish project metrics
- On assigned studies, provide leadership for the clinical operations project team, working in close collaboration with the CRA and other functional group leaders for the execution of all services according to the project-specific scope of work
- Ensure clinical studies are conducted according to all applicable regulations, company procedures, and high ethical/quality standards allowing for clinical trial documentation to be in audit-ready condition
- Prepare and/or facilitate the review of case report forms, protocols, investigator’s brochures/instructions for use, informed consent forms, study operations manuals and regulatory reports
- Assist in the development of electronic data management and device management systems
- Assist in the submission and review of all clinical deliverables required for regulatory submissions
- Support selected investigative sites for IRB/IEC/REB submissions, regulatory document collection and review, and budget and contract negotiations
- Collaborate with clinical operations administration to identify and oversee trial-related training and any performance concerns of team members according to their individual needs

Demands of the Position

- Graduation from a 4 year accredited bachelor’s degree program (or similar through experience)
- A minimum of 2 years of clinical project management experience
- Knowledge of medical terminology, Federal regulations and ICH-GCP, time management and problem solving skills, and the research process
- Strong experience in oncology, experience in medical devices is a big plus
- Excellent verbal and communication skills and be able to work independently
- Must demonstrate basic computer proficiency
- Demonstrate a high degree of personal and professional integrity

Terms of Employment

The contract will initially be a contract with The Clinical Company, you will first be outsourced to our client with the possibility of a direct contract after a period of time. Within The Clinical Company you will be part of a Benelux team of about 60 enthusiastic clinical professionals under the support of 2 dedicated Clinical Team Managers. Motivated, well trained and happy employees is essential to us in order to build a long lasting successful cooperation with our employees and clients. We therefore offer all the personal support you need, focus on your career development and make sure it’s fun to work for us!
Interested in this challenge and want to apply directly?! Please use the apply button below. For more information, feel free to contact Nick Dufour at 0032 (0)475 87 02 36 or n.dufour@theclinicalcompany.com.

Nick for Belgium

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+32 475 87 02 36n.dufour@theclinicalcompany.com

Simone for the Netherlands

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+316 12996359simone.polman@theclinicalcompany.com

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