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.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.