|Location: Cambridgeshire||Salary: £50 - £70 per hour|
|Sector: Pharmaceuticals, Client Delivery, Life Sciences||Type: Contract|
|Contact: Zak Mendoza||Job Published: 28 days ago|
Clinical Operations Manager
12-month contract (24 - 32 hours per week)
Clinical Operations Manager or Clinical Project Manager - Operations needed for a multinational Pharmaceutical organisation who are looking to employ an experienced and well-rounded Clinical Operations Manager that takes pride in their work with an in-depth knowledge of clinical study/externally sponsored research and drug development processes, knowledge and experience of relevant guidelines, e.g., GCP/ICH and experience of managing clinical trials.
What the role entails:
Some of the main duties of the Clinical Operations Manager will include:
- Form the EIU externally sponsored research (ESR) clinical trials management core team with the company's EIU Physician(s) and the EIU Supply Chain Manager
- Provide operational planning and delivery oversight for all EIU externally sponsored studies from set up to close out to facilitate delivery to agreed timelines.
- Attend biweekly EIU Clinical operations meetings to provide an update on all EIU ESR clinical trials, raise any concerns and contribute to solutions and mitigation planning.
- Regular study interactions to identify and resolve study specific issues and track recruitment.
- Drive rigorous recruitment feasibility assessments for all new EIU clinical trials
- Provide ongoing feasibility assessment and recruitment expertise to all EIU clinical trials.
- Coordinate ongoing drug supplies working closely with sites and EIU Supply Chain Manager
- Support continuous improvement, and contribute to the development and maintenance of guidance documents.
- Maintain project tracking system and provide monthly study updates to internal stakeholders
- Support Annual IB update and Pharmacovigilance activities working with external Pharmacovigilance Provider (Kinapse)
- Ensure compliance with the company's externally sponsored research (ESR) policies, processes and procedures, and all external regulations
- Provide expert input during the review of ESR clinical trial proposals and protocols ensuring adequate site feasibility during protocol development process.
What experience you need to be the successful Clinical Operations Manager:
- Extensive Pharmaceutical industry/CRO knowledge and experience of clinical study/externally sponsored research and drug development processes across multiple therapeutic and geographical areas.
- Knowledge and experience of relevant guidelines, e.g., GCP/ICH
- Project Management qualification or demonstration of extensive project management skills.
- Proven experience in driving operational delivery at a program level to time, cost and quality.
This really is a fantastic opportunity for a Clinical Operations Manager to progress their career. If you are interested, please apply as soon as possible as this position will be filled quickly so don't miss out!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.