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Precision for Medicine seeks a Senior Manager of Clinical Trial Management to lead the planning, conduct, and operational oversight of clinical studies. This role serves as the primary clinical point of contact with clients and is responsible for ensuring studies are conducted in accordance with protocol, SOPs, ICH-GCP guidelines, and all applicable regulatory requirements.
Key responsibilities include: developing study-related clinical documents (protocols, informed consent forms, case report forms, training materials); identifying and developing training needs for Clinical Research Associates (CRAs) and third-party vendors; generating site lists and driving the site feasibility process; developing recruitment and retention strategies; leading internal clinical team meetings and setting expectations for CRAs and Clinical Trial Assistants; addressing team and site questions; planning and conducting investigator meetings; overseeing submissions and approvals to regulatory authorities and IRBs; developing clinical monitoring strategies; implementing and managing electronic Trial Master Files (eTMF); collaborating on Corrective and Preventative Action Plans (CAPAs); preparing sites for GCP audits; managing investigational product accountability; negotiating site budgets and investigator contracts; and managing clinical vendors.
The role may include line management responsibilities and assumes project management duties when a dedicated PM is not assigned. The candidate will collaborate cross-functionally with project managers, data management teams, quality assurance, and legal departments.
Required qualifications: Bachelor's degree in science or health-related field (advanced degree preferred); minimum 7 years of clinical research experience with significant clinical monitoring experience. Required competencies include mastery of ICH-GCP and regulatory guidance, clinical management techniques, cross-functional collaboration, and functional management experience. Excellent communication, organizational skills, attention to detail, and ability to travel domestically and internationally required.
