Do you have experience as a Clinical Project Manager and are ready for a new challenge? 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!
Job Description
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. Occasional travel may required. The Clinical Project Manager may also participate in the development of SOPs, and internal monitoring processes.
Responsibilities
- As Clinical Project Manager, you will have the 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
- As Clinical Project Manager, you will have to develop clear and measurable project management plans and establish project metrics
- On assigned studies, the Clinical Project Manager will 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
- As Clinical Project Manager, you will 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
- As Clinical Project Manager, you will 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
- As Clinical Project Manager, you will assist in the development of electronic data management and device management systems
- As Clinical Project Manager, you will assist in the submission and review of all clinical deliverables required for regulatory submissions
- As Clinical Project Manager, you will support selected investigative sites for IRB/IEC/REB submissions, regulatory document collection and review, and budget and contract negotiations
- As Clinical Project Manager, you will collaborate with clinical operations administration to identify and oversee trial-related training and any performance concerns of team members according to their individual needs
- As Clinical Project Manager, you will plan, execute and lead study-specific meetings (e.g. project management meetings, investigator meetings, steering committee meetings, etc.)
- As Clinical Project Manager, you will provide all job-related progress reports/technical reports as requested.
- The Clinical Project Manager must perform related duties as required and assigned.
Requirements
- You hold a Master degree in lifesciences
- You have at least 2 years of clinical project management experience
- You have knowledge of medical terminology, federal regulations and ICH-GCP, time management and problem solving skills, and the research process
- You have excellent verbal and communication skills and be able to work independently
- You are familiar with Microsoft Office programs
- You demonstrate a high degree of personal and professional integrity
- You have very good oral and verbal communication skills in English and Dutch, French is an asset.
- You have the existing right to work in Europe.
Benefits
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
- A very flexible environment with a good work/life balance
- A full-time position
- A project with a duration of at least 1 year
- Open for freelancers as well
Vacancy number: 18546
