CK Science are recruiting for a Senior Project Manager, Clinical Operations, to join an exciting CRO which combines Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world.
This position can be homebased on a permanent fulltime basis.
To be responsible for the delivery and day-to-day management of allocated projects within the clinical operations department, ensuring projects are managed and delivered to time, quality and budget. To manage all operational aspects for implementation of clinical trial activities for assigned projects through duration of contract; liaise with the Regulatory Affairs, Medical Affairs, Data Management, Pharmacovigilance, Quality Assurance, Contracts and Proposals, Finance and Clinical Operations staff as applicable to ensure timely, high quality and profitable delivery of projects
- Science Graduate, or appropriate level of experience as a health care professional.
- A higher degree or Project Management qualification is desirable
- 5 years\' experience in study project management and prior management of contracted resources and/or vendors 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
- 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
- Experience with software systems (EDC, CTMS, eTMF, IXRS)
- Able to coach/mentor CRAs, In-House CRAs, CTAs and other Project Managers
- Line management of Clinical Operations department personnel as required
- Able to travel regionally and internationally as required
Entitlement to work in the USA is essential.
You MUST be eligible to work in United States. Learn more
- Agency: CK Group
- Contact: Amy Lloyd
- Phone: 01438 743047
- Reference: 50705
Website: CK Group
- Posted: 24th May 2021
- Expires: 21st June 2021