Clinical Project Manager - phase III
That's XPE. For one of our clients we are looking for: Clinical Project Manager - phase III Organisation description:
As International Clinical Project Manager, you'll manage all activities within Clinical Operations related to one or more clinical trial(s), including clinical study timelines, budget, and quality from Study synopsis until Clinical Study Report. You'll coordinate and lead the activities of different Study Team members. Our client is a clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies, based on its technology platform.Job description:
Your main responsibilities: 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 (e.g. in line with GCP/ICH guidelines) and adhering to the agreed project timelines and budget First point of contact for Clinical Operations-related questions for the given trial(s) Provide regular updates on trial evolution to the project teams and manager, and escalate any significant issues which may have an immediate impact on patient safety or conduct of the study, timelines, budget and/or data quality Contribute to timely development and/or review of trial-specific documentation (e.g., Protocol, Protocol amendments, Risk Management Plan , trial-related vendor documents…) Ensure the timely selection and qualification of CRO's and vendors, their training and management throughout the study Organize Kick-off Meetings, Investigators meeting and managing the CRO's output and responsibilities. Operational implementation of trial protocol, including coordination of trial-related activities with both internal (medical, regulatory, …) and external (CRO, central/referral labs) parties. Potential line manager of Clinical Trial Assistant(s) Contribute in process improvement activities within Clinical OperationsProfile:
You have at least 5 years of experience with international clinical operations in Pharma, Biotech or CRO (Phase III experience is a must, in respiratory diseases an asset) You have a medical or paramedical (e.g. pharmacy, biology, veterinary) degree Excellent knowledge of ICH, European directives and FDA guidelines related to GCP, experienced with adhering to SOPs and guidelines regarding the conduct of clinical trials You have Project Management and organizational skills You have good Communication skills. You are flexible, conflict handling and problem-solving skills, sense of innovation You are able to manage multiple and varied tasks and prioritize workload with attention to detail You have a good knowledge of written and spoken English (and French) You have knowledge of basic computer programs and experience with MS Project, by preference You're willing and capable to go the extra mile if needed.Offer:
A permanent contract (or freelance) in a biopharmaceutical company with a competitive package of fringe benefits (company car, ...) is waiting for your signature.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713