Basel, Basel, Switzerland
• Leading, managing and driving the planning and execution of assigned trials • Maintenance of study plan and budget negotiations with CRO. • Reviewing monitoring visits reports for assigned sites and countries • Reviewing and negotiating site contracts and investigator fees in collaboration with the legal team • Grants Manager (iMedidata) super-user: Setup and planning of budgets for several clinical trials in various indications (Neurology and Oncology), comparison to benchmark for contracts negotiation with sites and CROs. Therapeutic Area: Multiple Sclerosis
Set-up of two global phase III studies in Systemic Lupus Erythematosus (fully outsourced) Inspection readiness activities: FDA inspection at site (5 sites inspected worldwide) and sponsor MHRA inspection for a global phase III study in Multiple Sclerosis.
• Under the supervision of the clinical project leader: ensure study start-up activities are performed within the agreed timelines, budget and quality • Management and tracking of serious adverse events • Preparation of study specifications for outsourcing • Drafting of monitoring plan Therapeutic areas: Cardiovascular and Psychiatry
• Management of clinical trials in hepatogastroenterology, in collaboration with principle investigator, sub-investigators, study coordinators and study nurses • Attending patients’ visits and reporting data in electronic and paper CRFs • Preparing monitoring visits and site audit • Managing drug supplies stock in collaboration with the pharmacist