Senior Clinical Trial Manager
DescriptionDebiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world-wide marketing and sales.
For our Clinical Operations Department based at our Headquater in Lausanne, we are looking for aSENIOR CLINICAL TRIAL MANAGER
(100% - permanent contract)
The Senior Clinical Trial Manager (CTM) Ph III trials is reporting to the Director, Clinical Operations and, is responsible and accountable for leading, planning, implementing and delivering large international Phase III clinical trials in Oncology and onco-haematology, to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.
Your responsibilities :
- Lead the overall initiation, coordination, implementation and management of large international Phase III 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.
Your profile :
- University degree or equivalent in Life Sciences.
- Fluent in English – French and another European language are an asset.
- Oncology experience required.
- 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.
- Experience in external audits, an asset.
- Strong project management skills.
- 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.
- Willingness to travel according to business needs (10-30%).
- An international and highly dynamic environment.
- 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.