At a Glance
- Tasks: Oversee clinical trials, ensuring quality and compliance while collaborating with teams.
- Company: Dynamic pharmaceutical company blending innovation with real-world impact.
- Benefits: Competitive salary, global opportunities, and a collaborative work culture.
- Other info: Fast-paced environment with strong career growth potential.
- Why this job: Make a difference in patients' lives through cutting-edge research and therapies.
- Qualifications: Master’s in life sciences and 5+ years in clinical operations required.
The predicted salary is between 60000 - 80000 £ per year.
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.
Locations
Study Monitoring Lead in Cheshire, Warrington employer: RBW Consulting
Join a high-performing, research-led pharmaceutical company that champions innovation and real-world impact. With a collaborative culture and a commitment to meaningful therapies, this organisation offers exceptional employee growth opportunities and a dynamic work environment where your ideas are valued. Located in a vibrant setting, you will benefit from the agility of a biotech while being backed by an established international business, making it an ideal place for those looking to make a significant difference in the field of clinical trials.
StudySmarter Expert Advice🤫
We think this is how you could land Study Monitoring Lead in Cheshire, Warrington
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We think you need these skills to ace Study Monitoring Lead in Cheshire, Warrington
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at RBW Consulting!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show RBW Consulting that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at RBW Consulting!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At RBW Consulting, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at RBW Consulting
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at RBW Consulting that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with RBW Consulting’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
