£50k per year
11 months ago
My client, a niche CRO based in Hertfordshire, is looking to take on a senior clinical project manager. This is an excellent opportunity for established clinical trial/project managers to step into a leadership role and take on programme manager level responsibilities for a dedicated portfolio in a client facing role.
- Manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, as required
- Lead global and/or regional Clinical Study Management Team(s) in implementation of clinical trials, ensuring the studies are performed and conducted in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory requirements for the allocated study
- Liaise with the Medical, Regulatory Affairs & Drug Safety, Medical Affairs and Clinical Operations staff to ensure timely, high quality and profitable delivery of projects
- Act as clients' first point of contact- particularly with regard to the progress of the projects unless otherwise agreed. Maintain regular contact with clients by means of regular visits or TCs
- Keep and maintain records on the projects, coordinate meetings and TCs, circulate contact reports, raise purchase orders, track invoices and overall project progress
- Manage study-related vendors and serve as the primary point of contact for contractors as applicable identifying potential risks and resolving issues; conduct vendor selection and/or competency assessment as per Emas SOPs
- Provide input into and/or develop study related materials such as Trial Monitoring Plans, Communication Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study drug order forms as required
- Coordinate the negotiation of site budgets within guidelines, and provide oversight for site payments per contracts
- Perform and/or overseeing site monitoring visits for clinical trials as needed
- Review monitoring reports, protocol deviations and data listings for allocated studies to ensure reliable quality data are delivered; coordinating with Sponsor on site selection, IRB submissions, site initiation and close-out planning
- Track patient recruitment and progress to study timelines; supporting safety reporting and ethics committee submissions; maintain and report metrics for clinical site performance
- Provide oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with Emas SOPs
- Identify any out of scope activities and report to VP, Clinical Operations or designee and the Contracts and Proposals Department.
- Research subject and business areas in order to maintain a comprehensive understanding of the client's evolving objectives and ambitions for their products
- Be alert for possible new business opportunities and deal efficiently with any request for additional projects or services from clients. Liaise with the project director and other senior staff to develop proposals and budgets for these projects
- Work closely with Business Development personnel in identifying new clients and assist with the preparation of business proposals. Participate in bid defence meetings as required.
- At least 5 years' experience in Clinical Trial/Project Management
- Experience in cross-functional leadership or management
- Advanced knowledge and understanding of the principles of Good Clinical Practice and able to demonstrate practical application.