Real Staffing Cambridge, Cambridge, UK
Mar 28, 2017Permanent
The Senior Manager, Clinical Operations is responsible for the overall management of clinical studies in multiple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing. This position works with other team members to coordinate preparation of study protocols and final study reports. A detailed understanding of overall strategic direction; interrelationships and business needs is required Responsibilities include but are not limited to:- Managing all aspects of study progress from start-up to close-out activities to assuring adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, GCP, and ICH guidelines.- Coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing.- Collaborating with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.- Overseeing and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.- Communicating with study sites, proactively recognizing problem situations and informing team members to enable issue resolution- Contributing to individual and team development through training initiatives and team building activities. Advertised through Zoek.