Senior Clinical Project Manager
We are currently recruiting for an experienced Senior Clinical Project Manager to join our team in Q1 2020. The role is offered on a permanent, full-time basis. Work location is flexible however the individual will be expected to travel to our offices in Eccles and to meetings at other locations within the United Kingdom and Europe as required. The successful candidate will be responsible for the delivery and day-to-day management of complex projects within the clinical operations department.
- Manage all operational aspects for implementation of clinical trial activities from study start-up through to close out activities, as required (mostly Phase 2/3 but may be some Phase 1)
- Lead in the 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 other clinical and regulatory team members to ensure timely, high quality and cost-effective delivery of projects
- Act as CROs’ first point of contact – particularly regarding the progress of the projects
- Create 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 CROs as applicable; identifying potential risks and resolving issues; conduct vendor selection and/or competency assessment as per company 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
- Review monitoring reports, protocol deviations and data listings for allocated studies to ensure reliable quality data are delivered; coordinating with CRO on site selection, IRB submissions, site initiation and close-out planning
- Track patient recruitment and progress to study timelines; support 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 company SOPs
- Identify any out of scope activities and report to Clinical Operations Director or designee
- Research subject and business areas in order to maintain a comprehensive understanding of the evolving objectives and ambitions for company products
- Science Graduate, or appropriate level of experience as a health care professional
- Anti-infective, anti-fungal or oncology therapy experience an advantage
- At least 5 years’ experience in study project management and prior management of contracted resources is required; site monitoring and clinical quality compliance experience preferred
- Advanced knowledge and understanding of the principles of Good Clinical Practice and able to demonstrate practical application
- Advanced knowledge of drug development process and clinical study phases and competent level of clinical research literacy and use of terminology
- Proven project management skills; demonstrates competence in coordinating appropriately delegated tasks to pre-defined requirements, including planning, timelines, tracking and reporting
- Vendor management experience including internal contractors
- Accomplished user of Microsoft Office, ability to create and format documents to a good, consistent standard; efficient use of Internet.
- Demonstrated ability to communicate effectively in a range of electronic and face to face settings.
- Experience in clinical trial authorisation approval process in multiple regions
- Highly motivated, pro-active approach to tasks; able to work effectively within a team or independently.
- Excellent organisational skills and time management; able to prioritise tasks and work to timelines.
- Proven ability to identify issues proactively; good problem-solving skills.
- Proven ability to resolve routine issues effectively and independently
- Confident presentation skills; able to plan, prepare and deliver standard project-related presentations.
- Competent and confident to work effectively across company departments and with a variety of external vendors, using various modes of communication (email, letter, telephone).
To apply please send your CV and covering letter
stating current salary to:
Suzi Powell, Office Manager, F2G Ltd, Lankro Way, Eccles, Manchester M30 0LX