Clinical Study Manager – £450 per day (£60ph)

Our client, a global Biotech company based in Maidenhead, is looking for a Global Clinical Operations Lead (GCOL).

This role requires the candidate to possess drive, energy, and enthusiasm to deliver the program objectives, excellent written and oral communication skills, and a strong computer literacy.

This is a contract role to start ASAP for 12 months.

Key Responsibilities:

  • The on-time delivery of a clinical study (studies).
  • The clinical operational planning activities and leading study execution.
  • Working closely with the Senior Global Clinical Operations Lead (Snr GCOL) on a program or leads one or more studies and may take on additional responsibilities as dictated by study size and complexity.
  • Participating in or leading the study execution team (SET), oversees study level outsourcing, and takes preventive/corrective action(s) to address study level issues.

Key Skills/Experience:

  • Demonstrated ability to lead teams and work in a fast-paced team environment
  • Experienced in working within a Matrix Environment
  • Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report.
  • Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
  • Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
  • Extensive and comprehensive knowledge of ICH guidelines/GCP, Maintains current medical/scientific/regulatory knowledge.
  • Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
  • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
  • At minimum, bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
  • Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).

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