The Clinical Operations Lead I (COL I) serves as the clinical functional lead, responsible for site management and clinical monitoring activities across assigned studies and projects in accordance with defined scope. This role provides clinical leadership, mentoring, and technical guidance to the Clinical Operations team while ensuring high-quality deliverables, achievement of study milestones, and adherence to financial objectives.
Responsibilities:
- Provide clinical leadership, strategic planning, and operational oversight for assigned clinical studies and programs throughout all phases of study management, including study start-up, conduct, maintenance, and closeout, while ensuring adherence to applicable regulations, timelines, quality standards, and budget requirements.
- Support the identification, initiation, and engagement of clinical study sites, with a focus on patient recruitment and retention.
- Serve as a key point of contact for sponsors, study sites, vendors, and internal stakeholders regarding site management and clinical monitoring activities, ensuring timely and high-quality deliverables through CTMS, eTMF, and other tracking systems.
- Provide oversight and quality control review for the setup and ongoing maintenance of studies within Clinical Trial Management Systems (CTMS) and Trial Master Files (TMF).
- Plan and conduct initial and ongoing training for study teams on project-specific requirements, processes, and expectations, engaging therapeutic experts when appropriate.
- Drive successful site activation in accordance with established timelines, quality standards, scope, and budget parameters.
- Serve as the initial point of contact for clinical management and monitoring issues, coordinating with vendors and cross-functional teams and escalating issues as appropriate.
- Oversee the preparation, conduct, review, and timely completion of monitoring visit reports, ensuring appropriate documentation, follow-up, and resolution of site-level issues.
- Conduct monitoring visits, as needed, to support study execution and site performance.
- Provide ongoing leadership, mentoring, and technical support to Clinical Operations team members to promote consistent quality and successful study delivery.
Qualifications:
- Bachelor’s degree or RN in a life science or related field of study.
- 8 - 10+ years of clinical research trial and/or monitoring experience.
