Senior Clinical Operations Manager
For one of our clients, we are currently looking for a Senior Clinical Operations Manager for a contract based in Basel, Switzerland.
The ideal candidate should have experience in clinical operations/clinical trial management and excellent problem solving and team building skills.
- Directs the planning, set-up and conduct of trials (phase 1 to phase 3);
- Prepares trial budgets, forecasts, timelines, and project plans;
- Negotiates contracts and budgets for assigned clinical trials;
- Ensures close CRO surveillance and management of other third party vendors (central labs, IWRS/IVRS provider if applicable, secondary packaging);
- Manages the core team and delegates tasks to team members;
- Reviews clinical study protocols and provides input;
- Reviews and/or prepares other trial related documents (manuals, guidelines, visit reports, newsletters);
- Prepares clinical trial supplies projections and ensures the availability of a supply chain during the whole conduct of the trial;
- Performs UATs;
- Prepares and leads internal and external kick-off meetings, monitoring workshops and investigators meetings;
- Supervises training programs to assure consistency and compliance in conduct and monitoring of clinical trials;
- Prepares and distributes ad hoc reports, summaries, or analyses as required;
- Prepares status reports for assigned clinical trials;
- Conducts co-monitoring visits;
- Participates in internal/external audits;
- Participates in dissemination of clinical information to the core team members, as appropriate.
Qualifications and Experience:
- A minimum academic degree in Life Sciences, Pharmacy or Medicine is required
- An advanced academic degree (M.S., PhD, PharmD, or MD) is preferred.
- Minimum 7-8 years of progressively increasing clinical development experience within the pharmaceutical industry on a global level with experience in hospital and/or intensive care unit clinical trials
- Profound experience in clinical operations/clinical trial management especially in outsourced global phase III 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
- Ability to deliver oral presentations and write in a clear, focused, and concise manner
- Fluent written and spoken English is a must, German and French will be an advantage
- Relevant working/residency permit or Swiss/EU-Citizenship required.