18 days ago on ctcon.ch

Trial Operations Manager

CTC Clinical Trial Consulting AG

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  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Trial Operations Manager

Reference Number: 895010-W
Type of placement: Contract, 12+ months
Location: Switzerland, North West


  • Supports the Senior Clinical Operations Manager in the planning and conduct of global phase III trials.
  • Performs assigned responsibilities to ensure high quality data, safety of the patients, and timely completion of the trials.
Main Responsibilities:

  • Supports the planning, set-up and conduct of outsourced global phase III trials
  • Prepares trial budgets, forecasts, timelines, and project plans
  • Prepares contracts and budgets for assigned clinical trials
  • Supports close CRO surveillance and management of other third party vendors (central labs, IWRS/IVRS provider, secondary packaging)
  • 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
  • Participates in UATs
  • Supports the preparation of internal and external kick-off meetings, monitoring workshops and investigators meetings
  • Prepares and distributes ad hoc reports, summaries, or analyses as required
  • Prepares status reports
  • Conducts co-monitoring visits and reviews monitoring visit reports
  • Develops trackers
  • Writes and/or comments meeting minutes
  • Maintains knowledge of regulations, guidelines, policies, and practices for conducting global clinical trials
  • Participates in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, ICH-GCP, and regulations of regulatory authorities
  • Follows departmental policies, procedures, and SOPs
Qualifications and Experience:

  • Minimum 3-5 years of progressively increasing clinical development experience within the pharmaceutical industry
  • Experience in clinical operations/clinical trial management especially in outsourced global phase III trials
  • Infectious diseases experience is an advantage
  • Monitoring experience
  • An advanced academic degree (M.S., PhD, PharmD, or MD) is preferred
  • A minimum academic degree in Life Sciences, Pharmacy or Medicine is required
  • Problem solving and team building skills
  • Ability to resolve and make judgements regarding administrative, scientific and/or clinical problems with minimal 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