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Clinical Site Operations Manager

1 month ago

Macon, Georgia, United States Macon, Primary Pediatrics Full time
Job Summary

The Manager, Site Operations is responsible for overseeing the clinical operations staff, training and onboarding of new staff, and ensuring the quality and compliance of clinical work at the site. This role works closely with and in support of the Site Director, performing coordinator and supervisor duties, and filling in during the absence of site coordinators. The Manager, Site Operations must be able to work independently and with all staff and customer levels.

Responsibilities
  • Work with the Site Director to meet/exceed the site's financial, operational, and study-specific targets.
  • Support the identification of strategies to expand the research capabilities at the site, in line with the overall site business plan.
  • Support the implementation and maintenance of VCR quality standards at the site, ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs.
  • Work with the Site Director to address any study and/or clinical quality-related matters.
  • Ensure timely and appropriate communications occur with Sponsors and IRBs as necessary.
  • Support the development of site staffing plans to ensure the successful and efficient conduct of research studies.
  • Identify and fulfill any site resource needs necessary to successfully conduct and/or recruit research studies.
  • Support or lead the development of the patient recruitment plan and patient outreach process for studies.
  • Manage the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development, and responsibility.
  • Communicate performance expectations and guidelines to site staff members.
  • Identify and manage issues, concerns, and problems related to staff conduct and performance.
  • Identify and build relationships with outside medical practices, pharmacies, and other healthcare professionals/organizations to aid in the patient recruitment process.
  • Support business development activities on behalf of the site and VCR with sponsors, CROs, CRAs, and any third-party study vendors, as appropriate.
  • Share best practices with other VCR site locations with the goal of raising the overall level of operational competencies at VCR.
  • Support the completeness, accuracy, and timeliness of Feasibility Questionnaires, CDAs, CVs, and essential regulatory documents from study start-up phase until site initiation.
  • Attend industry and VCR meetings relevant to the position of Manager, Site Operations.
  • Manage facility and IT needs to ensure smooth and efficient operations.
Qualifications
  • Expertise in project management.
  • Knowledge of field organizational strategies.
  • Extensive knowledge of clinical research.
  • Strong communication and presentation skills.
  • Able to generate business correspondence, create forms, and generate reports as required.
  • Practices professionalism and integrity in all actions.
  • Demonstrated ability to foster concepts of teamwork, cooperation, self-control, and flexibility to get the work done.
  • Ability to communicate effectively in English (both verbal and written).
  • Up to 10% travel, as needed, for project team meetings, client presentations, and other professional meetings/conferences as needed.