Senior Clinical Operations Manager (M/F)
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). It focuses on products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and potentially life-threatening conditions.
To strengthen our Development Department, we are looking for a motivatedSenior Clinical Operations Manager (M/F)Your tasks
- Lead the planning, set-up and conduct of outsourced global phase 3 trials
- Manage the core team and delegate tasks to team members
- Manage the CRO and other third party vendors (central labs, IWRS/IVRS provider, secondary packaging)
- Negotiate contracts and budgets for assigned clinical trials
- Review and/or prepare trial related documents (manuals, guidelines, visit reports, newsletters)
- Prepare trial budgets, forecasts, timelines, and project plans
- Prepare clinical trial supplies projections and ensure the availability of a supply chain during the whole conduct of the trial
- Lead internal and external meetings, monitoring workshops and investigators meetings, including all preparations
- Conduct co-monitoring visits
- Minimum 5 years of progressively increasing clinical development management experience within the pharmaceutical industry on a global level with experience in hospital and/or intensive care unit clinical trials
- An advanced academic degree (M.S., PhD, PharmD, or MD) is preferred.
A minimum academic degree in Life Sciences, Pharmacy or Medicine is required
- Profound experience in clinical operations/clinical trial management especially in managing outsourced global phase 3 trials
- Monitoring experience
- Excellent leadership/ management skills including excellent problem solving and team building skills
- Excellent communication and presentation skills
- Ability to resolve and make judgements regarding administrative, scientific and/or clinical problems without supervision
- Fluent in written and spoken English, German and French are desired
We offer an interesting and varied work environment in a dynamic future-oriented enterprise with a highly motivated team, a competitive salary and benefits.
We look forward to receiving your online application including your complete documents. For additional information please contact Ms. Nadine Pfrüner.