For a growing company in the region of East-Flanders, we are looking for a Clinical Trial Lead (Project Manager).
- Do you several years of experience as project manager in clinical research?
- Do you have a first experience with vendor/CRO management?
- Are you a pragmatic, open and target-oriented problem solver?
Then don't hesitate to contact me for further information!
The Clinical Trial Lead is responsible for all activities within clinical operations related to 1 or more clinical trials. This includes planning, implementation and management of single and multi-site clinical studies. The CTL collaborates with the trial team members from the other departments working on the given trial and too coordinate all study-related activities. You are responsible for CRO/vendor management.
- Responsible for the operational aspects during the planning, start-up, conduct and close-out phase of the given trial(s) while ensuring the quality and the integrity of the data (cfr GCP/ICH guidelines) and adhering to the agreed project timelines and budget.
- First point of contact for Clinical Operations-related questions on the given trial(s).
- Provide regular updates on trial evolution to the teams (Clinical Trial Team) and to the Clinical Operations Lead and escalate any significant issues which may have an immediate impact on patient safety and conduct of the study.
- Contribute to timely development and/or review of trial-specific documentation (e.g., Protocol, Protocol amendments, Clinical Trial Responsibility Assignment Form, trial-related vendor documents).
- In collaboration with the Clinical Operations Lead, ensure the timely selection and qualification of vendors, their training and management throughout the study. Review and approval of vendor proposals, contract, invoices and escalation of any out of scope services and budgets which require management approval.
- Organise Kick-off Meeting, Investigators meeting and ensure the CRO is organising the Monitors meeting.
- Operational implementation of trial protocol, including coordination of trial-related activities with both internal (medical, regulatory, clinical supplies, data management, biostatistics, pharmacology, quality, legal, ... ) and external (CRO, central/referral labs, vendors) parties.
- Potential line manager of (Jr)Clinical Trial Lead(s) and/or Clinical Trial Assistant(s) including tasks such as but not limited to: performance planning and appraisal, approval of holidays.
- Potential mentor of Clinical Trial Lead(s) and/or Clinical Trial Assistant(s) including providing training on trial specific knowledge.
- Team Player
- Project Management and organizational skills
- Conflict handling, problem solving and innovation
- Being accountable: exercising judgemen, impact of decisions/consequence of error
- Able to manage multiple and varied tasks and prioritize workload with attention to detail
- Good knowledge of English
- Computer knowledge
- Excellent knowledge of ICH GCP and European directives, FDA guidelines and applicable SOPs and guidelines regarding the conduct of clinical trials
- Contribute to the development and improvement of departmental procedures, processes, and templates
- Able to work with limited supervision
- Several years of experience as Clinical Project Manager
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