About this role
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. The role will 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). Working closely with the Chief Investigator (Professor Josip Car) and the EMBRACE Chief Operating Officer, the post holder will play a key role in ensuring that clinical trials are delivered safely, efficiently and to the highest scientific and ethical standards. The role requires substantial experience in clinical trial management, with demonstrable expertise in regulatory compliance, ideally within an academic or complex multi-partner research setting. As a senior member of the programme leadership team, the post holder will shape the regulatory strategy for EMBRACE and contribute to design, delivery and monitoring across the portfolio of studies. They will 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. This is a full-time post (35 hours per week), and you will be offered a fixed term contract until 31/12/2029. 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
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)