Job Description

Site Engagement Manager (SEM)

About the Role

We are seeking a Site Engagement Manager (SEM) to act as a key liaison between the Sponsor and clinical trial sites. In this role, you will drive site relationships, patient recruitment, and trial engagement strategies, ensuring high-quality execution and strong investigator partnerships throughout the clinical trial lifecycle.

This position operates within an FSP model and reports directly to the FSP CRO Line Manager, while working closely with Site Engagement leadership and project teams.

Key Responsibilities

Site Relationship Management & Engagement

• Serve as the primary point of contact between the Sponsor and assigned clinical trial sites.
• Act as the “face” of the Sponsor, building and maintaining strong, long-term relationships with investigators and site staff.
• Maintain frequent engagement with sites (on-site visits, virtual meetings, calls, emails, webinars) to ensure ongoing trial awareness and priority.
• Promote the Sponsor’s mission, pipeline, and values to strengthen engagement and collaboration.

Site Performance & Recruitment Optimization

• Support patient recruitment and retention strategies across assigned sites.
• Analyze enrollment performance to identify risks, barriers, and improvement opportunities.
• Develop and execute tailored site engagement plans based on individual site needs.
• Assess the impact of competing trials and treatment patterns on recruitment.

Operational Support & Collaboration

• Collaborate with Study Teams to ensure investigators fully understand protocol requirements, eligibility criteria, and study procedures
• Provide feedback from sites, including suggestions for protocol improvements and operational enhancements.
• Support feasibility assessments, Pre-Selection Visits (PSVs), and Site Initiation Visits (SIVs) in partnership with CRAs.
• Participate in Investigator Meetings and Site Engagement initiatives.

Risk Management & Compliance

• Identify and proactively manage site risks and performance issues, escalating when needed to protect timelines and outcomes.
• Ensure sites operate in compliance with SOPs, regulatory requirements, and quality standards
• Escalate any compliance or quality concerns appropriately.
• Contribute to the development and improvement of SOPs and working practices when applicable.

Cross-functional Alignment & Communication

• Maintain clear and consistent communication with investigators, coordinators, and site teams.
• Relay training needs and support site readiness on study protocols and reporting.
• Collaborate with cross-functional teams to ensure alignment and successful study execution.

Portfolio & Site Management

• Manage approximately 20–25 investigator sites on average, potentially across multiple studies.
• Actively identify and engage new investigators through various channels (conferences, literature, networks, etc.).

Qualifications & Experience

• Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
• 5+ years of experience in clinical research, clinical operations, or site management.
• Strong understanding of ICH-GCP, clinical trial processes, and regulatory requirements
• Proven experience working directly with investigators and clinical sites.
• Experience in patient recruitment and site engagement strategies is highly preferred.
• Demonstrated ability to manage multiple sites and priorities simultaneously.

Key Skills & Competencies

• Excellent stakeholder engagement and relationship management skills
• Strong communication and influencing abilities
• Analytical mindset with a focus on performance optimization
• Proactive problem-solving and risk mitigation
• Ability to thrive in a matrix, cross-functional environment

Why Join Us?

• Opportunity to play a strategic role in clinical trial success and patient access
• Work in a collaborative, global environment within an FSP model
• Contribute to strengthening site relationships and improving trial outcomes

Additional Information

• Assigned sites: ~20–25 sites on average
• Ability to support multiple trials simultaneously
• Access to Sponsor systems as applicable (excluding restricted systems)

Learn more about our EEO & Accommodations request here