Global (Senior) Clinical Trial Manager Phase I II
Debiopharm Group, Switzerland
Job Description
Debiopharm Group (Debiopharm) is a Swiss-based biopharmaceutical group 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.
To join our Clinical Operations Department based in Lausanne, Switzerland, we are looking for
Global (Senior) Clinical Trial Manager Phase I amp; II
The Global 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
Requirements
- University degree or equivalent in Life Sciences.
- Mininum 6-8 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%).
Benefits
- 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.