Senior Clinical Operations Manager

Reference Number: 895678-W
Type of placement: Contract, 12 months
Location: Switzerland, North West

Introduction:

Main Responsibilities:

  • Directs the planning, set-up and conduct of pediatric 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

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