Do you have experience as a Clinical Project Manager or are you able to lead a team to success? Do you have Medical Device experience or are you interested in making the step into the world of (Cardiac) Medical Devices? This might be the job for you!
Under the direction of the Associate Director, Clinical Operations, the Clinical Project Manager has responsibility for the comprehensive management of clinical studies and communication with study sites and sponsors. The Clinical Project Manager may also participate in the development of SOPs, and internal monitoring processes.
- 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
- Plan, execute and lead study-specific meetings (e.g. project management meetings, investigator meetings, steering committee meetings, etc.)
- Provide all job-related progress reports/technical reports as requested. 11. Perform related duties as required and assigned.
- 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
- 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
- Very good oral and verbal communication skills in English and Dutch, French is an asset.
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
- Full Time position
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17159