Clinical Trial Operations Manager

Job type:
on-site
Start:
07/2018
Duration:
08/2019
Place:
Basel-City
Date:
06/22/2018
Country:
flag_no Switzerland
project ID:
1583747

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We are recruiting for a Trial Operations Manager for a global position within a multinational pharmaceutical company.

You will be responsible for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out. This role is a great mix of strategic and operational duties where planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical and delivery of data, sites close-out, audit and inspection preparation activities will be some of the main responsibilities.

This is a 1 year contract position; with further extensions in place.

Responsibilities:
  • In compliance with regulations you will execute trials according to plans and timeline, commitments in alignment with strategy to achieve global and regional objectives.
  • Communicates planned milestones to Trial Monitoring stakeholders and update on operational activities at the Region/Country level, during the course of the trials to meet Objectives
  • Participates 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
  • Actively participates in the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete operational data within corporate systems.
  • Develops planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and cleaning) using available internal and external resources (patients' incidence, competitive landscape regional strategies, data, statistical plan)
  • Is accountable for recruitment activities; responsible for forecasting, setting up contingency planning to ensure recruitment targets are achieved in accordance with trial execution plan.
  • Evaluates potential challenges/risks within the protocol and operational aspects of the study in line; assessing impacts, developing risk management plans and communicating/escalating to appropriate stakeholder


Requirements
  • Advanced degree, preferably in life sciences
  • Fluent English (oral and written)
  • 3+ years' experience in clinical research, in planning/executing and/or monitoring clinical trials
  • Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
  • Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but can coordinate the activities of others
  • Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
  • Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
  • Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
  • Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations.


Please contact luchele Mendes on +41 (0)

Michael Bailey International is acting as an Employment Business in relation to this vacancy.