- Entry level
- No Education
- Salary CHF80,000.00 - CHF100,000.00 gross per year
The firm is a biopharmaceutical company.
- You will be accountable to manage the initiation, coordination, implementation and management of large international Phase III clinical trials from the start-up to close out.
- Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation.
- You will lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met.
- Manage operational and technical aspects of projects including budgeting, study initiation and risk management.
- Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required.
- Select, manage and coordinate external vendors, such as Contract Research Organizations, central laboratories, etc.
- You will represent clinical operations on multi-function project teams internally and externally; report on study progress.
- Monitor vendor and CROs performance and ensure continuous oversight.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans;
- You will ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company's specific SOPs.
University degree or equivalent in Life Sciences.
- Fluent in English - French and another European language are an asset.
- Large scale experience is critical.
- Oncology experience is desirable.
- Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO.
- Previous monitoring experience preferred.
- Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.
- Experience in management of CROs, vendors and consultants.
- Eperience in contributing to protocols and clinical development plans.
- Experience in external audits, an asset.