Senior Clinical Operations Manager
CK Clinical are recruiting for a Senior Clinical Operations Manager to join a small Global Pharmaceutical Company at their site based in Central London on a permanent basis.
The main purpose of the role will be to have a high level of oversight and manage clinical trials, predominantly in early phase in the Neurology, Immunology and Rare Disease areas. This may either be directly or through providing leadership in managing/directing the internal/external study team members. The role holder will be fully accountable for ensuring that the timeline, budget, quality and integrity of clinical trials is consistent with the clinical study protocols and other study requirements.
Responsibilities will include to:
- Oversee, supervise, mentor and assist clinical operations, when required, to ensure adherence to agreed project plan, budget, and quality specifications for individual clinical trials.
- Be the primary contact for all study operational management related communications, including for managing/answering questions related to trial procedures and patients' eligibility.
- Monitor and report the study progress and quality, analyzing potential issues and risks, and escalating/resolving them as appropriate.· Monitor, assess and report on their performance and quality of work (especially to ensure that CRAs are monitoring the study as expected).
- Provide input to study documents, including e.g., but not limited to, study protocol, statistical analysis plan, clinical study report, audit plan, and/or author relevant sections of study documents.
- Organise and chair the monthly project meeting(s).
- Organise study meetings/training as required.
- Minimum BSc in the Life Sciences, Nursing degree, or equivalent combination of education and experience.
- Significant demonstrable clinical research experience gained within a contract research organisation (CRO), pharmaceutical, or Biotechnology Company, with proven experience of technical and/or project management in conducting multi-national and/or single site early phase clinical trials in a pharmaceutical company or CRO.
- Thorough knowledge of regulatory requirements, clinical development, and clinical monitoring procedures.
- Demonstrable experience of leading project/study teams.
- Ability to oversee and manage CROs throughout the entire clinical operations life cycle of a study.
- Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
For more information or to apply for this Senior Clinical Operations Manager position, please contact Sam Whyley-Smith on 01246 580040 or email email@example.com, quoting job ref 48241.
It is essential that applicants hold entitlement to work in the UK.