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Senior Clinical Operations Manager

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Job Description - Senior Clinical Operations Manager

....a highly motivated Senior Clinical Operations Manager for our Development department.
  • Lead the planning, set-up and conduct of clinical trials (phase I to III)
  • Preparing trial budgets, forecasts, recruitment projections and project plans
  • Negotiating contracts and budgets for assigned clinical trials in cooperation with Finance Department and Project management
  • Management and surveillance of CRO(s) and third party vendors 
  • Leading the internal study team and working with relevant functions to deliver the trial within timelines, budget and with high quality 
  • Reviewing clinical study protocols from operational standpoint and providing input as well preparing trial related documents (manuals, guidelines, visit reports, newsletters)
  • Performing UATs
  • Planning and leading project meetings, training workshops and investigators meetings 
  • Supervising training of study team members to assure consistency and compliance in conduct and monitoring of clinical trials
  • Preparing and distribution regular and ad hoc reports, summaries, or analyses as required  as well status reports for assigned clinical trials 
  • Conducting co-monitoring and oversight visits and participation in internal/external audits
  • Minimum 9 years’ experience in clinical trials phase I – III and and minimum 2 years as Clinical Trial Manager
  • Experience working hands-on on phase I, II and III studies in cross-functional environment at a CRO or study sponsor 
  • Strong understanding of various functions’ contributions in the set-up and conduct of clinical trials
  • Solid understanding of common clinical trial systems (EDC, IRT, eTMF, CTMS, etc.)
  • Sound knowledge of ICH-GCP and clinical trial regulations across regions and countries
  • Excellent communication skills across all levels, internally, externally, cross-functionally and in a highly collaborative matrix environment
  • Excellent team and problem solving skills in international and cross-functional environment
  • Fluent in English, spoken and written, any other language is considered beneficial
  • Willingness to travel
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