For one of our clients, we are looking for an experienced Clinical Project Manager.
- Do you have a University Degree in Life Sciences?
- Do you have at least 2 years of experience as Clinical Project Manager?
- Are you fluent in English?
Then, you might be the candidate that we are looking for !
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 (Occasional travel may required).
- You execute and manage all aspects of multi-center global clinical trials independently from concept to close-out within designated project budgets and timelines
- You develop clear and measurable project management plans and establish project metrics
- On assigned studies, you 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
- You 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
- You 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
- You assist in the development of electronic data management and device management systems
- You assist in the submission and review of all clinical deliverables required for regulatory submissions
- You support selected investigative sites for IRB/IEC/REB submissions, regulatory document collection and review, and budget and contract negotiations
- You collaborate with clinical operations administration to identify and oversee trial-related training and any performance concerns of team members according to their individual needs
- You plan, execute and lead study-specific meetings (e.g. project management meetings, investigator meetings, steering committee meetings, etc.)
- You provide all job-related progress reports/technical reports as requested.
- You perform related duties as required and assigned.
- You have a University Degree in Life Sciences
- You have at least 2 years of experience as Clinical Project Manager
- You have a strong 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 are able to work independently
- You demonstrate basic computer proficiency
- You demonstrate a high degree of personal and professional integrity
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