AD Business Operations

Key Responsibilities

• Monitor, control, and report vendor performance against timelines, deliverables, budget, and quality standards.
• Lead vendor performance and governance meetings, including the establishment of key performance indicators (KPIs) and key risk indicators (KRIs).
• Serve as the primary point of contact for external service providers (CROs, EDC platforms, laboratories, and other vendors).
• Develop scopes of work, manage contracts, and oversee invoice approval in partnership with business operations.
• Ensure inspection-ready documentation for all sponsor obligations transferred to vendors.
• Author and maintain vendor governance plans and lead governance meetings.
• Proactively identify vendor risks and implement mitigation strategies.
• Partner with Quality Assurance on vendor audits and with IT Security to ensure appropriate security controls are in place.

Provider Qualification & Risk Assessment

• Manage the end-to-end process for provider identification, qualification, selection, and ongoing relationship governance.
• Lead the development and evaluation of Requests for Information (RFIs) and Requests for Proposal (RFPs).
• Develop systems and tools to support consistent, efficient, and repeatable outsourcing processes.
• Schedule, host, and evaluate vendor presentations.
• Monitor and support continuous improvement initiatives with key providers.

R&D and Clinical Outsourcing Strategy

• Drive the R&D outsourcing strategy in collaboration with cross-functional teams to meet both project-specific and organizational needs.
• Conduct industry research and market surveys to remain current with best practices in clinical outsourcing.
• Identify, screen, and maintain relationships with potential and existing providers.

Qualifications

• Education & Experience: Bachelor’s degree required. Minimum 8 years of experience in clinical trial management. Minimum 3 years of experience managing others, either as a direct line manager or as a leader of matrix clinical trial teams. Experience leading clinical trial activities outside the U.S. and/or in emerging markets is preferred.
• Required Skills & Competencies: Strong written and verbal communication skills with experience presenting to cross-functional groups. Proficiency with clinical trial systems, clinical data management systems, MS Office, and electronic document management systems. Demonstrated ability to lead multi-disciplinary teams toward the achievement of project goals. Strong organizational and planning skills with the ability to manage multiple priorities. Proven ability to work autonomously under consultative direction toward long-term objectives. Skilled at anticipating problems and developing effective solutions for complex situations. Strong negotiation skills and ability to build collaborative relationships across internal functions and with external partners. Ability to communicate effectively at all levels of the organization and with external vendors.

Travel Requirements

Business travel approximately 30%. Standard office environment with a weekly commute to the assigned office location.