What are the responsibilities and job description for the Senior Clinical Trial Manager (New York, NY) position at CEDENT?
JOB DESCRIPTION:
- 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.
- Bachelor’s degree or higher required (science-related degree required)
- Excellent knowledge of medical terminology and familiarity with clinical trial process required
- Strong ICH-Good Clinical Practice knowledge
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
- Ability to travel an estimated 10% on average
