King's College London
Senior Clinical and Regulatory Programme Manager
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About Us
King’s College London is an internationally renowned university delivering exceptional education and world-leading research. We are dedicated to driving positive and sustainable change in society and realising our vision of making the world a better place. We are delighted to announce exciting new opportunities to join our community.
EMBRACE
EMBRACE is a visionary, multicomponent international research programme, the first of its kind in the world, supported by Inkfish with £35M core funds over six years, starting in April 2025. It is a global study of 60,000 participants, including 20,000 mothers, 20,000 infants and up to 20,000 partners. It brings together world-leading clinician scientists across six distinguished Healthcare organisations, world-leading AI & technology companies, together with premier biotech companies, with the overarching aim to fast-track major scientific breakthroughs, revolutionise maternal and early childhood health through precision-personalised interventions, powered by a groundbreaking symbiosis of cutting-edge AI combined with human support.
About the Role
The EMBRACE Senior Clinical and Regulatory Programme Manager will lead the operational delivery and regulatory oversight of clinical trials within the EMBRACE programme. The post holder will be responsible for establishing, implementing and monitoring high standards of clinical trial conduct across all participating sites, ensuring compliance with international regulatory requirements, Good Clinical Practice (GCP), and relevant quality frameworks.
- Provide leadership across a complex, multi-country research environment, overseeing trial operations, regulatory approvals, and the implementation of data capture systems (e.g. EDC platforms and mobile technologies)
- Ensure robust standards for data integrity, governance and privacy, in line with applicable data protection legislation (including GDPR) and institutional policies
- Work closely with the Chief Investigator (Professor Josip Car) and the EMBRACE Chief Operating Officer, ensuring that clinical trials are delivered safely, efficiently and to the highest scientific and ethical standards
- Shape the regulatory strategy for EMBRACE and contribute to design, delivery and monitoring across the portfolio of studies
- Lead regulatory submissions and act as the first point of contact for regulatory authorities, lead contracting negotiations with sites, commercial partners and regulatory bodies, and establish the programme’s Quality Management System (QMS), including programme-specific Standard Operating Procedures (SOPs), training and compliance frameworks
- Provide line management to junior trial coordinators and trial monitors as the programme team expands
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This is a full-time post (35 hours per week), and you will be offered a fixed term contract until 31/12/2029.
The successful candidate will be required to work across two sites: Guys Campus and Denmark Hill.
About You
To be successful in this role, we are looking for candidates to have the following skills and experience:
Essential Criteria
- Degree (or equivalent) in a relevant health related subject/expertise (e.g., Medical, Scientific, Nursing, Pharmacy) and a post graduate qualification with a research methodology element
- Substantial experience of working in research or clinical trials, with an understanding of GCP guidelines, including in international multi-site trials
- Experience of line managing staff, including clinical research staff (e.g. trial coordinators, monitors), performing objective-setting, performance review and development
- Demonstrable experience of leading contract and governance negotiations with clinical sites, commercial partners and/or regulatory bodies on behalf of a research programme or sponsor organisation
- Demonstrable experience of leading regulatory strategy and submissions across multi-country clinical research programmes, including direct interaction with regulatory authorities (e.g. MHRA, EMA, FDA or international equivalents) as a primary point of contact
- Proven ability to assess and manage risks in clinical trials, including the development and implementation of appropriate mitigation strategies
- Knowledge of project management methodologies, with the ability to apply these in practice to support effective trial delivery
- Strong IT and data management skills, including experience of clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and Microsoft Office Suite and experience of establishing and owning a Quality Management System, including authorship of programme- or organisation-level SOPs, and oversight of training and compliance frameworks
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Desirable Criteria
- Formal qualification in clinical trials or clinical research (or working towards one)
- Project management certification (e.g., PRINCE2, PMP) and/or Certification in clinical research (e.g., ACRP, SOCRA, or equivalent)
- Experience in the field of study of the trials (pregnancy studies, digital and remote trials, with an AI component)
- Track record of contribution to regulatory policy, guidance or thought leadership relevant to programmes such as EMBRACE (healthcare AI, digital health or international clinical research)
- Able and willing to travel internationally as required (around 10 days per year)
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