Senior Clinical Project Manager – Pharma – English Fluent – Vaud
My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their global clinical team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Senior Clinical Project Manager to plan and manage overall clinical operations for assigned global clinical trials/programs.
You will serve as a project team member and coordinate the overall clinical program activities with other functions (e.g. RA, CMC) including long-term, next stage planning and may supervise other CPMs as part of the overall clinical program.
Activities and responsibilities:
Plan and conduct Clinical Studies:
- 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 and Clinical Protocol.
- Ability to manage complex phase 3 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 clinical supplies to determine IP requirements.
- 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.
- Works with outsourcing manager and clinical team to establish budget and timelines for the study.
- 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 the Clinical Trial registry (clinical.trial.gov).
- Manage the lesson learn meeting.
- Manage subcontractors (CROs, experts …):
- Works with Outsourcing manager to prepare Clinical outsourcing specifications.
- Participate in the selection of CRO.
- Review the CRO contract including scope of services.
- Supervise adherence to scope of work within timelines and budget.
Quality and process:
- Contribute and initiate process improvement initiatives.
- Collaborate with other department members to promote harmonization of all processes and procedures.
- Involve in documents quality control.
Budget and planning:
- Establish project 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.
- Follow-up closely the recruitment rate of the study and take appropriate corrective actions, if needed.
- Make a risk assessment of the study and update it on a regular basis.
- Track all aspects of the Clinical Trial and make regular progress reports.
- Develop communication through newsletters to inform investigators and/or affiliates.
- On a regular basis, update management with project milestones, costs, and projections for future activity (be able to provide various scenario/proposal/actions)
Project Team Representative (PTR):
- Participate in the overall project planning, optimization and consolidation with the Project Team.
- Works closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the Project.
- Report progress on deliverables to the Project Team and identify variances and present solutions/alternatives.
- Responsible and accountable for Operational aspects of the clinical project in terms of timelines, costs and resources.
- Proactively evaluates risks at operational level and builds alternatives or contingency plans for discussion and arbitration within the Project Team.
- University degree, preferably in a biologic/scientific discipline
- Minimum of 10 years progressive experience in clinical operations including 5 years of clinical project management or equivalent with Pharma/Biotech and/or CRO
- Systemic route of administration clinical trials experience required; paediatric, drug/device combination and biologics experience preferred.
- Thorough understanding of country level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
- Ability to travel 30%
Please send your CV to Jean de La Fournière: email@example.com