Clinical Operations Manager – Hertfordshire (Hybrid)
A leading healthcare business specialising in medical devices and pharmaceuticals is searching for a Clinical Operations Manager to lead its Clinical Affairs function in Hertfordshire. This hybrid role offers the opportunity to play a strategic part in driving the company’s clinical operations programme and shaping evidence generation for both new and existing products.
Your responsibilities as the Clinical Operations Manager will include:
- Leading the company’s clinical research programme, ensuring compliance with GCP, ISO 14155, and MDR regulations.
- Acting as the strategic link between Clinical Affairs, Product Research, and Regulatory teams to develop clinical evidence strategies.
- Overseeing the planning, execution, and reporting of clinical investigations, observational studies, and PMCF activities.
- Managing vendor relationships, including CROs and academic partners, ensuring alignment with company standards.
- Ensuring adherence to regulatory and ethical requirements, and supporting pharmacovigilance and safety reporting processes.
- Leading, developing, and mentoring the Clinical Operations team to deliver high-quality research and compliance excellence.
To be successful as the Clinical Operations Manager, you will need to demonstrate:
- A degree in life sciences, pharmacy, or a related discipline.
- Significant experience in clinical operations or clinical research management within medical devices or pharmaceuticals.
- Strong knowledge of GCP, ISO 14155, EU/UK MDR, and related guidelines.
- Proven experience managing interventional and non-interventional clinical studies.
- Excellent leadership, communication, and project management skills.
This is a hybrid role based in Hertfordshire, offering the chance to contribute strategically within a supportive, growing, and innovative healthcare organisation.
Clinical Operations | Clinical Affairs | Medical Devices | Pharmaceuticals | Clinical Research | GCP | ISO 14155 | MDR | PMCF | Hertfordshire | Hybrid | Clinical Studies | CRO Management | Clinical Governance | Healthcare | Quality | Compliance
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