Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
To join our Clinical Operations Department based in Lausanne, Switzerland, we are looking for
Senior Clinical Trial Manager
The Senior Clinical Trial Manager (CTM) reports to the Director, Clinical Operations and, is responsible and accountable for leading, planning, implementing and delivering international clinical trials in Oncology and/or Bacterial Infections, to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.
Your key responsibilities:
- Lead the overall initiation, coordination, implementation and management of international clinical trials from start-up to close out.
- 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.
- Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation.
- Select, manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc.
- Monitor vendor and CROs performance and ensure continuous oversight.
- Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required.
- Represent clinical operations on multi-function project teams internally and externally; report on study progress.
- 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.
- Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs.
- Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents.
- Design, review and approve of all trial related documentation, and establish trial processes.
- University degree or equivalent in Life Sciences.
- Minimum 8-10 years of experience as a global Clinical Trial Project Manager in the Pharmaceutical Industry.
- Oncology and/or Infectious disease experience is strongly desirable.
- Strong project management skills.
- 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.
- Experience in external audits, an asset.
- Excellent budgeting, planning, and communication skills.
- Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency.
- Ability to lead and influence a cross-functional study team and external partners.
- Strong negotiation skills.
- Strong scientific knowledge and involvement.
- Former experience in contributing to protocols and clinical development plans.
- High degree of initiative and ability to work independently.
- Fluent in English – French is an asset.
- Willingness to travel according to business needs (10-30%).
Debiopharm can offer you
An international and highly dynamic environment, with a long term vision.
The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.