Clinical Project Manager - Boston Biotech Hub - Massachusetts - USA

dependant on experience
04 Aug 2017
16 Aug 2017
Clinical Project Manager - Boston Biotech Hub - Massachusetts - America - Small European CRO - Home-based Upsilon Global are proudly partnered with a small European CRO looking to expand operations into America. Our client, a successful and highly reputable contract research organisation, is looking for a CPM experience in both regulatory and clinical affairs within the Boston Biotech Hub. As the first US-employee, you will play a vital role in American operations, liaising with and running studies across US and Europe. As such, our client is seeking international clinical project managers with a proven track record in the set-up and delivery of clinical studies across Europe and the USA. Background Details confidential, information available upon request. This is an exciting company of roughly 80 people currently. With 3 offices in Europe, they are looking to launch on the east coast of America. They have a strong infrastructure in place to support long-term growth, an exceptional management team and a strong belief in internal progression and development. 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 five years of general clinical research experience, including on-site monitoring experience. - Must have a minimum of one to two years of experience in the management of clinical trials as a project manager - Prior supervisory experience is required. - 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 via email 'applications (at) upsilonglobal . com' or the assigned contact number.