International Senior Clinical Project Manager
My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton.
Due to this growth my client is looking for an International Senior Clinical Project Manager with strong experience in global clinical trial management.
- Responsible for leading and managing the multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
- Responsible for the development of the Clinical Trial Outline (CTO) and Clinical Protocol.
- Ability to manage complex phase III clinical trial programs.
- Manages selection of study vendors for assigned studies.
- Manages vendor(s) throughout the life of assigned clinical trial(s).
- Selects investigational sites with input from Clinical Development and vendors.
- Reviews and refines Clinical Operations Plans including monitoring and other plans.
- Works with operations to oversees investigative sites’ adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel & CRAs.
- Provide input and contribute to the other study related documents.
- Plans and conducts investigator meetings, training sessions and KOL meetings as required.
- Review clinical regulatory documentation for the study submission including but not limited to CTA modules, IB, IMPD, EC, safety reports, labels.
- Works with CS, ME and project team as appropriate to develop the Clinical Study Report.
- Identifies and provides solutions to clinical trial issues or risk.
- Provide input together with the Clinical Project Team on responses to Health Authority questions and/or Ethic Committee/IRB.
- Mentors staff and serves as a resource for new employees.
- Provides or facilitate training to clinical study teams on protocol specific topics.
- Participates as appropriate in internal and external audits.
- Manages communication of study status and guidance to internal stakeholders.
- Manage subcontractors (CROs, experts …):
- Milestones and establish budget and timelines for the study conduct together with the study team. Establish a detailed planning of clinical project.
- Build, follow-up and close out study Budget following internal templates and instructions and according to the initially approved budget.
- Track all aspects of the Clinical Trial and make regular progress reports.
Your profile :
- University degree, preferably in a biologic/scientific discipline
- Minimum of 10 years experience in clinical operations including 5 years of clinical project management or equivalent with Pharma/Biotech and/or CRO
- Experience working on phase II and III at international level
- Ability to travel 30%
For more information please send your profile to email@example.com