Clinical Operations Lead
An exciting contract role has arisen for a Contract Clinical Operations Lead in Berkshire. This is an amazing opportunity for a bright individual to combine your experience with a well-established pharmaceutical organisation.
- Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans
- Leverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issues
- Ensure all operational aspects support end point integrity and data validity.
- Develops and leverages Phase expertise (e.g. Phase I, II, III, IV), therapeutic knowledge, as well as internal and external data to develop protocols and experts operational strategy for one or more clinical studies.
- Overseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO
- Driving performance, quality, timelines and relationships through the CRO partnership model
- Partnering with Vendor Management to escalate issues, sharing best practices and leveraging the Vendor Operations Relationship Manager for issue resolution.
- Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group
- Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model
- Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.
Skills and Requirements
- Education B.A. or B.S. in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management skills.
- Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development.
- Requires a balance of scientific and operational/project management and team leadership expertise.
- Excellent project management skills, including risk assessment and contingency planning.
- Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model.
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
- Experience At least 10 years of clinical research study management experience of which at least 4 years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 0207 440 0639 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.