Contract Clinical Trial Manager (Remote, East Coast)

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.

Background

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.

Main responsibilities

• 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’