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Trial Operations Manager (m/f)...

 
 
 

Trial Operations Manager (m/f) 100%

For our client, an international pharmaceutical company, we are in search for a Trial Operations Manager. As Trial Operations Manager you are accountable for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out, in collaboration with GCT/ICT/CTTs, regions and countries (COs), in compliance with the internal processes, GCP, ICH and regulatory requirement.

What the company offers:

  • International environment
  • 40 hours per week, which is less than the Swiss average
  • Company easily reachalbe by car or public transportation
  • Clinical project for 2 years

Your responsibilities:

  • Participating in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
  • Participating actively in the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete operational data within corporate systems
  • Developing planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, start-up, aata collection and cleaning) using available internal and external resources (patients’ incidence, competitive landscape regional strategies, data, statistical plan)
  • Reviewing, approving, and ensuring updates to CCGs as appropriate during trial conduct
  • Performig user acceptance testing for EDC system
  • Contributing to the development of the data handling and review plans

Your profile:

  • College or university degree with significant life science experience
  • Fluent English skills (oral and written)
  • At least 5 to 8 years experience in clinical research, in planning/executing and/or monitoring clinical trials
  • Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
  • Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations and clinical development process

Welcome to nemensis!

We are looking forward to getting to know you!

Ihr direkter Kontakt:

Paulina Soszynska
Kägenstrasse 18
4153 Reinach

Tel.: +41 61 205 98 92
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