Switzerland
Posted 2 years ago
Key responsibilities:
- Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration
- 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, timelines and risk management
- Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
- Manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
- 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, if need[1]ed; 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:
- Bachelor or master’s degree or equivalent in Life Sciences
- Proven track record of 5-7 years of experience as Global Clinical Trial Manager or comparable operating experience in Pharma (sponsor), including experience leading global Phase I & II studies from set-up to close-out
- As Global Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology (a must)
- As Global Clinical Trial Manager, you have worked on studies including radiopharmaceutical compounds
- Experience in leading global clinical studies in Phase III is an asset
- Experience in pharmacokinetic studies (e.g. DDI, ADME) is an asset
- Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus)
- Customer oriented and strong team-spirit with the ability to foster a collaborative team envi[1]ronment and to work effectively with others in a fast-paced matrix organization
- Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
- Experience in external audits, an asset
- Strong negotiation skills, scientific knowledge and involvement
- Former experience in contributing to protocols and clinical development plans
- Fluent in English – French is an asset
- Travel: up to maximum 20%
Job Features
| Job Category | CLINICAL DEVELOPMENT, LIFE SCIENCES |