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.
- 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.
- 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).