Senior Clinical Trial Manager

Oversight and management of clinical trials with emphasis on interactions with investigators, study coordinators, and data managers at investigational sites; identification of potential recruitment issues, and preparation and review of all trial related documentation (including clinical protocols, Investigator Brochures, Informed Consent Forms, etc.). Works closely and directly with cross-functional staff including drug-supply, regulatory, data management, safety and QA. Special focus working with and directing Clinical Research Associates and Site Coordinators. • Organize and conduct training for internal team, site personnel and vendors. Conduct start-up activities including site qualification, budget negotiation, site initiation meetings in collaboration with a Contract Research Organization. • Oversee and track trial-related activities (i.e., screening and enrollment metrics, data entry and quality, monitoring plans, collection of laboratory samples). • Ensure regulatory compliance for trial conduct Track and ensure appropriate trial specific materials. • Organize, participate in and document conference calls and meetings to review trial progress. • Continuously track and check eCRFs. Ensure that data queries are responded to in a timely fashion. Ensure proper collection, tracking and review of SAEs. Confirm compliance with all regulatory requirements. • Maintain all trial related documentation including: IRB approvals; CVs of investigators and study personnel; clinical IB; protocols; instructions and training material; ICFs; CTM shipping orders; start-up meeting attendance documentation; letters of agreement; all investigator and site correspondence. Participate in clinical departmental planning sessions, and SOP development. Maintain close interaction with the CRO involved in the study, and work with the clinical research assistants from the CROs to ensure that their role and contribution is optimized.