Clinical Site Director - Remote

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Full Time Knoxville, TN, US

5 days ago Requisition

The Clinical Site Director is responsible for managing the overall business and clinical operations of individual sites to ensure that appropriate targets are met. The Clinical Site Director is responsible for managing the site’s annual and forecast operating budgets and for the efficient coordination, organization and conduct of clinical trials. The Clinical Site Director oversees and manages all aspects of the clinical trial process including study feasibility, clinic staffing, patient recruitment, study conduct, quality, and regulatory compliance in collaboration with respective functional groups.

This individual will work closely with senior leadership, site investigators, and external stakeholders to guide AMR in developing innovative, ethical, and high‑quality research programs.

To consistently embody AMR Clinical’s Core Values:

• United We Achieve
• Celebrate Diverse Perspectives
• Do the Right Thing
• Adapt and Persevere

Clinical Site Director will report to SVP, Clinical Operations

Classification:
Exempt

• Work with the Senior Vice President, Clinical Operations to manage the operational budget and meet/exceed the site’s financial, operational, and study‑specific targets.
• Ensure financial targets are met by optimizing resource allocation and identifying cost‑saving opportunities.
• Identify and implement strategies to expand the research capabilities at the site — in line with AMR’s overall business and growth plans.
• Oversee the implementation and maintenance of AMR quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs and AMR SOPs.
• Accountable for ensuring delivery across multiple sites according to the contracted scope, timeline, and budget, in accordance with AMR’s SOPs, GDP, GCP, and ICH guidelines and all applicable regulations.
• Identify and share lessons learned and best practices across programs, building relationships with key stakeholders cross‑functionally, across all levels.
• Provide technical and operational leadership for the site portfolio inclusive of:
  • Ensuring achievement of operational and financial targets through active participation in the Risk Review Process and routine review of metrics and KPIs via the available suite of data and reports.
  • Ensures quality standards are set and maintained over all areas of responsibility. Ensures adherence to CAPA and QI timelines and outcomes for assigned sites.
  • Identify opportunities to expand into new therapeutic areas.
  • Assist in recruiting new staff, including participation in the interview process. Proactively work to ensure staff retention and turnover rates remain within expected levels.
  • Review workload for all staff in the reporting chain, participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced, and staffing needs are identified in a timely fashion.
  • Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
  • Participate in operational and department level financial reviews.
  • Identify potential risks to trial progress or site performance and lead efforts to mitigate those risks. Handle operational challenges independently and elevate issues to the SVP when necessary.
• Provides oversight to site teams in driving management of financial aspects of assigned studies to ensure adherence to the financial process flow (e.g., executed contracts, forecasting, invoicing, etc.).
• Serve as an escalation point for sites, customers and internal partners. If needed, participate in meetings to discuss escalation with internal/external partners.
• Rapidly identify key issues in complex situations. Includes and leads appropriate participation in informal problem‑solving teams when appropriate and brings alternatives integrated…