Vendor & Site Compliance Manager

The Position

Provides strategic leadership, functional expertise, and operational oversight at the regional level. The role oversees and coordinates strategic Clinical Research Organization (CRO) partnerships and local vendor management, ensuring operational delivery, quality, contractual, and financial oversight in alignment with global standards, regulatory requirements, and organizational objectives. This role is accountable for driving quality and compliance in the planning, preparation, and conduct—including monitoring—of clinical programs across Clinical Development Operations (CDO).

Tasks and responsibilities

Vendor Management & Operational Coordination:

• Act as main contact for CRO/vendors, managing communications and staff transitions.
• Oversee and coordinate strategic CRO global partners and local vendors, including FSP services.
• Implement outsourcing strategies aligned with global trial oversight deliverables.
• Execute vendor management strategy locally, covering operational delivery, quality, contracts, and financial oversight.
• Lead vendor processes and regular performance meetings.
• Assess CRO/vendor performance against KPIs and provide feedback.
• Manage issue resolution and escalation to ensure timely study execution.
• Coordinate vendor staff onboarding and system access.
• Develop tools and processes to enhance performance at regional level.
• Define service scope and specifications with stakeholders.
• Provide resource projections and monitor availability for projects.
• Collaborate on work order and contracting processes with Global Vendor Partnerships and Sourcing.
• Facilitate training and change management for CRO operating model implementation.
• Monitor industry trends and communicate risks to leadership.
• Ensure qualification and oversight plans for local vendors per procedures.

Site Compliance Leadership

• Identify, develop, and implement strategic CDO quality initiatives and inspection readiness activities.
• Guide trial teams in CAPA plans and ensure adherence to quality standards.
• Design and report metrics to assess quality trends and compliance issues.
• Lead strategic decision-making and resolve complex cross-organizational issues.
• Coordinate inspection readiness and participate in regulatory inspections.
• Identify risks and lead mitigation strategies with timely follow-up.
• Execute quality process improvements and training programs for continuous development.
• Share lessons learned across the regional CDO organization.
• Represent functional quality and compliance in local/global working groups.
• Serve as main contact for process-related questions and knowledge transfer to CDO team.

Requirements

Required

• Minimum B.S. degree.
• At least 5 years' clinical research experience.
• Professional experience in pharmaceutical industry or CRO.
• Comprehensive knowledge of clinical research and operational processes.
• Previous experience leading cross functional teams.
• Strategic vision and business acumen.
• Understanding of local/regional regulations, compliance frameworks, and standard of care.
• Experience working with CROs and external experts.
• High competency in technology and digital tools.
• Advanced in english.