RBW Consulting are partnered with a high-performing, research-led pharmaceutical company where innovation meets real-world impact. With global reach and Scandinavian roots, they combine cutting-edge science with a collaborative, no-nonsense culture to bring meaningful therapies to patients across oncology, respiratory, and beyond.
Known for their agility and strong pipeline, they offer the best of both worlds — the backing of an established international business with the pace and mindset of a biotech. It’s a place where decisions happen, ideas are valued, and people genuinely make a difference.
Purpose of the Role
The Study Monitoring Lead (SML) is responsible for the day‑to‑day operational oversight of clinical trials, with a focus on feasibility, site management, and monitoring execution. The role ensures studies are delivered to protocol, timelines, regulatory standards, and quality expectations.
Key Responsibilities:
Feasibility & Site Selection
- Oversee feasibility activities, assessing countries/sites for capability, patient access, and operational fit
- Support country and site selection in collaboration with study team and CROs
Site Set‑Up & Management
- Drive site activation readiness (IMP, labs, contracts, regulatory documentation)
- Oversee enrolment, data quality, and protocol compliance
- Review/validate study plans (e.g. monitoring plans, lab manuals) and patient materials (ICF, leaflets)
- Oversee CRO/vendor performance for monitoring and site management
- Support training of CRAs/sites and resolve operational challenges
- Ensure effective on-site and remote monitoring, including co-visits and issue follow-up
- Contribute to additional study-level activities, including co-monitoring if required
Study Tracking & Delivery
- Track key metrics (activation, enrolment, monitoring, deviations) and report to leadership
- Oversee sample logistics and central assessments
- Support IMP supply and reconciliation with key stakeholders
Cross-Functional Collaboration
- Partner with internal teams (data, safety, regulatory, supply) and CROs/vendors
- Conduct sponsor site visits and maintain strong site relationships
Risk & Quality Management
- Identify and escalate risks/issues at site or study level
- Ensure compliance with GCP, protocol, and SOPs, maintaining inspection readiness
Requirements:
As you can see from the duties above this role would suit someone coming from a Clinical Trial Manager / Senior Clinical Trial Manager background.
Essential
- Master’s degree in life sciences (or related)
- 5+ years in clinical operations, including 3+ years monitoring oncology studies
- Strong experience in feasibility, site selection, and site oversight
- Solid knowledge of ICH-GCP and global clinical trial processes
- Strong collaboration, communication, and site engagement skills
- Hands-on, detail-oriented, proactive problem-solver
- Willingness to travel internationally
Desirable
- Experience in small biotech or fast-paced environments
Next Steps:
Please apply here and Harry Henson will be in touch to discuss your application W/C June 22nd
