Highlights:
- Manage the clinical site team and site operations
- Lead and manage a site from a strategic level and help the site become successful
- Work with a smaller, but face paced, clinic; Great Teamwork!
The Role
The Site Manager is responsible for directly overseeing the day-to-day clinical operations including planning, organization, and implementation of all aspects of daily clinical research functions. Ensuring optimal conduct of studies, maintaining protocol compliance, meeting clinical data quality standards, optimizing operational flow and continuous monitoring/oversight of clinical trial operations. Also the management and supervision of all research personnel such as overseeing goal performance
- Directly manage site staff
- Manage staffing needs and maintaining staff (interviews, training, performance reviews, etc)
- Mentor and support direct reports in their responsibilities and functions.
- Develop and refine subject visit flow and subject binders to ensure on time data capture by properly delegated staff for each subject visit
- Manage and track vital trial metrics and operational objectives for the trial are in conformance to all relevant laws, regulations, GCP guidelines, protocol, and internal SOPs/policies.
- Study start up, ensure all protocol requirements are met, ordering of proper supplies, development of vendor relationships, coordinate staffing and proper coverage
- Distribute studies among coordinators, considering the site, coordinator, subject, experience, training & sponsor needs.
- Participate in the conduct of PSSVs, SIVs and introduce self to all CROs, Project Managers, CRAs
- Provide back-up for appropriate study tasks, as dictated by patient flow and staff coverage
- Maintain oversight of accurate and efficient data entry into all systems
- Address all patient, vendor, and sponsor complaints
- Facilitate the Quality Control process
Qualifications:
- 5+ years Clinical Research experience at the site level
- 3+ years direct people management experience
- Strong leadership and business minded!
