As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
Working in a fast-paced, client-focused global environment, our Clinical Team Managers are at the heart of our project teams and our company. As a Clinical Team Manager you will create and maintain all relevant clinical project documents and tools pertinent to the study, ensuring compliance with company, applicable regulatory and customer requirements. You will need to ensure consistent implementation of PRA methodologies during the different phases of the study.
You will serve as the primary liaison and primary point of escalation for clinical activities and team issues, interacting with clients, vendors and other PRA functional areas. Leading a team of Clinical Operations colleagues (CRAs, In House CRAs and Start Up Leads) you will work with the Project Manager to build and foster the client relationship and provide data as required for clinical performance metrics and project status metrics - applying and drawing conclusions between project activities/deliverables and project metrics and initiating measures to improve metrics. Your focus will be on proactive risk identification and management, including implementation of CAPAs where applicable.
You will liaise with Clinical Operations Managers to resolve resource and performance issues and contribute to Business Development activities participating in proposals and bid defenses as needed. Additional tasks include trip report review, forecasting and project management of the study start up process across your region.
The successful candidate for the Clinical Team Manager role will have a relevant degree or be a licensed health-care professional. Additional requirements include a thorough knowledge of ICH GCP and an awareness of local and international regulatory authority regulations. Successful candidates must have a considerable amount of experience in clinical research / clinical operations with at least several years’ experience of managing clinical projects, including providing leadership in a multi-country / international setting. Your experience of leading a clinical team to successful project delivery will be clearly evident. Finance management and forecasting skills will ensure success within this role.