Contract Clinical Trial Manager (Remote, East Coast)
- Experience Level
Contract Senior Clinical Trial Manager - Small US CRO working direct for Sponsor - Remote, East Coast
As part of some recent internal reorganisations, one of our small CRO partners are looking for a Contract Senior Clinical Trial Manager at 1.0 FTE/100% allocation to work directly for the Sponsor on an exciting large-scale, nationawide GI study, with the possibility of working on multiple, upcoming projects as well!
Due to the nature and size of the project, we are looking for a highly experienced Contract Senior Clinical Trial Manager, with at least 5 years of Clinical Trial Management experience.
Details confidential, information available upon request. Small American CRO based on the East Coast, working with a GI-specialist sponsor based in North Carolina. Excellent opportunity to progress into a more stable permanent position if this is something you are interested in.
- Responsible for overall project planning and execution for multiple clinical protocols.
- Responsible for the overall management of site monitoring and associated documentation from study initiation through close-out to ensure compliance with regulatory requirements and Good Clinical Practice.
- Establishes and maintains productive working relationships with vendors, clinical investigators, and clinical site study staff to ensure quality of deliverables.
- Ensures that protocol/project training (on-site and Investigator Meeting) for Investigators, Monitors and other key study personnel is conducted and appropriately documented.
- Responsible for the study budgets management.
- Provides guidance to study team ensuring adequate management of the project Trial Master File.
- Visits sites on regular basis to monitor compliance with the protocol. Provides mentoring, and ensures adequate training and monitoring is in place.
- Undertakes ongoing performance review, feedback and development of staff.
- Assists with talent recruitment and leads a highly motivated, efficient and effective team.
Education and Qualifications
- A Bachelor's degree in a scientific or health-related field is required.
- Master's degree in a scientific or health-related field is preferred.
- Minimum of 10 years of general clinical research experience, including on-site monitoring experience.
- Must have a minimum of 5 years of experience in the management of clinical trials as a project manager
- Advanced understanding of GCPs and ICH guidelines is required.
Other skills and abilities
- Must demonstrate a keen attention to detail and timelines.
- Excellent writing, communication, and presentation skills.
- Demonstrated leadership and project management skills.
- Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on ‘+44. 20. 3. 87. 5.9. 966’ or email ‘ application (at) upsilonglobal . com’