What are the responsibilities and job description for the Clinical Site Engagement & Monitoring Excellence Consultant position at EPM Scientific?
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.