Job Summary The Manager, Clinical Site Operations reports to the Director, Clinical Site Operations, and functions as the direct manager for patient-facing site staff supporting assigned studies. This role supervises clinical trial activities, the implementation of and adherence to study protocols, and oversees the schedules of assigned site staff to ensure best utilization of all resources and overall capacity planning. Additionally, the Manager is responsible for ensuring quality and adherence to standard operating procedures as well as federal and local regulations for all assigned studies.
Job Responsibilities
- Supervise a subset of clinical research coordinators, both on-site and remote-based staff, as well as any other supporting staff of the clinical site that are working directly with patients.
- Drive accountability for patient enrollment, ensuring Clinical Research Coordinators own the enrollment plan to meet recruitment goals for their specific studies.
- Manage assigned staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations.
- Oversee the schedules of assigned site staff to ensure best utilization of all resources and overall capacity planning.
- Work with Director of Site Operations to evaluate and implement new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the sites.
- Support deployment and use of all clinical trial technology utilized by the sites (e.g., eSource, eReg, eConsent).
- Ensure the highest standard of integrity, quality, and operational excellence in clinical research activities and adherence to Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA, and other applicable federal, state, and local regulations for all assigned studies.
- Participate in the conduct of initial and ongoing risk assessments and develop plans for approaching identified risks.
- Collaborate with the site project management and quality functions to convert newly identified Walgreens’ locations into fully operational and compliant clinical trial sites.
- Work closely with the clinical site quality function to ensure the Walgreens’ clinical trial sites are audit-ready at all times.
- Coordinate with the clinical site project management function to facilitate monitoring visits, audits, and other interactions between site staff and sponsors for assigned studies.
- Contribute to the development and ongoing revision of clinical site processes, procedures, templates, and other relevant organizational tools.
Basic Qualifications
- Deep understanding of the drug/device development process including new clinical trials models.
- Exceptional working knowledge of ICH-GCP, US CFR, and HIPAA regulations.
- Experience working independently and making appropriate strategic decisions to operationalize and move clinical trials forward.
- Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail.
- Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities.
- At least 2 years of experience contributing to financial decisions in the workplace.
- At least 2 years of direct leadership, indirect leadership and/or cross-functional team leadership.
- Willing to travel up to/at least 25% of the time for business purposes (within state and out of state).
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