Contract Clinical Trial Manager (Remote, East Coast)

Upsilon Global - USA - 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’... - Permanent - Full-time

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