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| Clinical Trial Lead PA Open (J#45739) Title: Clinical Trial Lead Company: Thomson Reuters Description BioMed Valley Discoveries - Clinical Trial Lead Position Established by the non-profit Stowers Institute for Medical Research, BioMed Valley Discoveries is a for-profit translational research and development organization dedicated to bringing new medicines and diagnostics to the clinic in areas that are considered too early, too risky or too small for biotech and pharmaceutical companies. Well capitalized, BioMed Valley Discoveries is uniquely positioned to pursue therapeutic and diagnostic projects addressing unmet medical need across a range of disease areas and stages of preclinical and clinical development. BioMed Valley Discoveries is headquartered in Kansas City, MO with a Boston satellite office. Position Purpose: Responsible for the planning and implementation of all operational aspects of assigned clinical studies from protocol synopsis to reporting according to timelines, budget, operational and quality standards. Organizational Relationships: - Reports to the clinical program Director of BioMed Valley Discoveries - Close collaboration with peers in Translational Medicine, Project Management, Regulatory Affairs and outside collaborators in academia and CROs. - This position is located in Boston area, MA. Responsibilities - Contribute to the clinical protocol development process. Accountable for the development of protocol amendments and trial-related documents and processes in collaboration with the clinical CRO team; solicit input from Key Opinion Leaders (KOLs) and investigators to ensure their feedback is adequately integrated into protocol. - Contribute to the development of clinical sections of regulatory documents like Investigators Brochures, briefing documents, IND/NDA submission documents, responses to Health Authorities questions. - Serve as the primary contact for the CRO clinical operation team for clinical conduct of the trial. Contribute to identification and evaluation of new centers suitable for performing clinical studies in healthy volunteer and patients. - Work closely with clinical CRO teams on all trial start-up activities including budget, contract negotiation, IRB documents, pre-study & site activation visits, and all activities as dictated by protocol amendments. - Manage the clinical operation team at the CRO(s) to ensure all trial deliverables are met according to timelines, budget, and resource requirements; Report study progress and issues with their resolution plan to the clinical program Director at BioMed Valley Discoveries. - Lead trial level interactions with Drug Suppliers. Responsible for drug supply management. - Responsible for investigator/site relationship management. Develop effective working relationship with key investigators to optimize scientific quality and efficiency of clinical study execution and reporting. - Forecast trial resources needs: accountable for the development, management and tracking of trial budget working closely with CRO teams. Requirements Qualifications - Ph.D. level scientist or equivalent in the life science background; PharmD. - 4 or more years operational experience in planning, executing and reporting clinical studies in a pharmaceutical company or contract research organization. - Familiar with clinical drug development and regulatory processes. | |||
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