Senior Director, Clinical Research Operations & Quality

Company Description

Privia Health™ is a national physician platform transforming the healthcare delivery experience. We provide tailored solutions for physicians and providers, creating value and securing their future. Through high-performance physician groups, accountable care organizations, and population health management programs, Privia works in partnership with health plans, health systems, and employers to better align reimbursements to quality and outcomes.

Job Description

The Senior Director, Clinical Research Operations & Quality is a key leader and integral member of Privia’s Clinical Research team, tasked with delivering operational excellence, quality, and patient safety across Privia’s national network of research sites.  Day-to-day, this role will partner closely with program and market leadership, medical directors, investigators, and external service partners to continuously improve operational performance, ensure consistent delivery of high-quality research operations across all Privia sites and markets, execute national and market-level growth strategies, develop and implement new capabilities and tactics to drive patient engagement, and achieve financial and budgetary goals.

A successful candidate will be an experienced clinical research site operator (multi-site) and leader willing to stretch into new and different tasks as the business requires.  The ideal candidate will have direct experience in trial operations, a proven track record leading a multi-site operation with P&L responsibility, deep understanding of clinical research compliance, quality and regulatory issues, a strategic mindset, and a passion for engaging with physicians to drive performance improvement.

Key Responsibilities:

• Oversee and manage clinical research operations, external service partners, quality assurance/risk management activities, and national program growth in close partnership with internal and external stakeholders 
• Lead strategic planning, budgeting, goal setting, and implementation of the infrastructure, processes and systems necessary to scale efficient, safe, and high-quality clinical trials
• Manage cross-functional team resources and external service providers to conduct clinical trials on time, on budget, in compliance, and of highest quality
• In partnership with external service providers, develop best practices, methods, techniques, and operational standards for clinical research across Privia’s site network
• Provide direction and oversight of quality and risk management activities, including identification, tracking, and investigation of potential issues, compliance with existing policies and procedures, regulations, standards, and guidelines, and development/monitoring of risk mitigation plans and CAPAs as necessary.
• Perform/manage internal audits to ensure adherence to quality standards, operational best practices, and to identify potential risks to trial performance or patient safety; report related deficiencies and associated risks to senior leadership as well as plans for risk mitigation and corrective and/or preventive actions (CAPA).
• Partner with Medical Directors to educate investigators, other providers and clinical staff on ongoing research activities, participation opportunities, and to train on operational best practices and workflows
• Coordinate review of contracts, legal agreements, and study budgets in collaboration with external service providers and legal/compliance teams
• Collaborate with national and local leadership teams to evaluate and develop new strategies to grow and diversify clinical research
• Responsible for delivery of reporting, dashboards, and insights (weekly, monthly) to customers, internal stakeholders, and leadership
• Manage communication of priorities to ensure execution of goals and milestones through regular meetings, status updates, and other written communications
• Willingness to travel to partners and customers in existing and new markets
• Expand the firm’s knowledge base in clinical research and emerging opportunities
• Perform other duties as assigned or required

Colorado, New York, New Jersey, California and Washington Residents Only: The salary range for this role is $136,000 to $204,000 in base pay and exclusive of any bonuses or benefits. The base pay offered will be determined based on relevant factors such as experience, education, and geographic location.

Qualifications

• Bachelor’s degree required; clinical training or advanced degree preferred
• 10+ years of relevant work experience showing career progression in clinical research site operations including P&L responsibility and accountability for multi-site network operations
• Industry-specific certifications (e.g. ACRP-CP, CCRC, CCRA, ACRP-PM, etc) preferred
• Front-line