Clinical Site Engagement & Monitoring Excellence Consultant

EPM Scientific are currently partnered with a growing, late-stage biotech organisation supporting global clinical development programmes. They are actively strengthening their Site Engagement and Monitoring capability and are seeking an experienced Senior Manager to support delivery across early- to late-phase clinical studies. See a short summary below:

Contract Conditions:

• Start date: ASAP
• Location: Hybrid (3 days onsite/ week in Jersey City or South San Francisco during non-travel periods)
• Contract Type: Contract / Consultant - Full-time, 12-month initial duration
• Language: English
• Project: Global Clinical Trials (Early-Late Phase, cross-therapeutic)

Key Responsibilities:

• Provide oversight and operational leadership of site engagement and monitoring activities across global clinical studies
• Act as a senior escalation point and Subject Matter Expert (SME) for site management and monitoring quality issues
• Build and maintain strong relationships with clinical trial sites, investigators, CRO partners, and internal study teams
• Lead, train, and mentor CRAs to ensure high-quality site qualification, initiation, monitoring, and close-out activities
• Perform monitoring oversight activities to assess CRA performance, data quality, and inspection readiness
• At times, undertake CRA responsibilities directly to support urgent site qualification, initiation, or monitoring needs
• Support development and implementation of Corrective and Preventive Action (CAPA) plans where required
• Support inspection readiness activities and partner with Clinical Quality teams during site and sponsor inspections
• Contribute to monitoring process improvement initiatives, including development of SOPs, Work Instructions, job aids, and tools

Requirements:

• Bachelor's degree with 8+ years' relevant experience or Postgraduate degree with 6+ years' experience
• Extensive hands-on monitoring experience within Pharma, Biotech, or CRO environments
• Proven experience leading, mentoring, and overseeing CRAs
• Experience operating within a Functional Service Provider (FSP) or embedded sponsor model
• Prior experience supporting or participating in regulatory inspections (site and/or sponsor)
• Strong experience using CTMS and TMF systems (Veeva preferred)
• Willingness to travel to sites (~50%, variable depending on study needs)

If this role is of interest, please apply directly to learn more. If not, feel free to share with relevant contacts.