Global (Senior) Clinical Trial Manager Phase I & II (6 months assignment) (BB-253A8)
Gefunden in: Talent CH
Debiopharm GroupTM (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 & II - (6 months assignment)
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