SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Precision for Medicine seeks an experienced Clinical Trial Manager to lead the planning, conduct, and 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 feasibility process; developing recruitment and retention strategies; leading internal clinical team meetings and managing CRA/Clinical Trial Associate expectations; addressing team and site questions; supporting investigator meetings; overseeing submissions to regulatory authorities and IRBs; developing clinical monitoring strategies; managing eTMF implementation; collaborating on Corrective and Preventative Action Plans (CAPAs); preparing sites for GCP audits; managing investigational product accountability; and ensuring data quality and compliance.
The role may include project management responsibilities when a dedicated PM is not assigned, vendor management (labs, IP, patient diaries), clinical data review, site visit report review, and potential line management responsibilities. Candidates should have strong communication and interpersonal skills, excellent organizational abilities, attention to detail, and a customer service orientation. Travel (domestic and international) is required.
Minimum qualifications: Bachelor's degree in science or health-related field with 7+ years of clinical research experience, including significant clinical monitoring experience. Advanced degree preferred. Proficiency with Microsoft Office products required.
