Senior Study Management Specialist

Role Summary

We are seeking an experienced clinical research professional to join the RWE team at Costello Medical. This position will be based within our Study Management sub‑team, which leads the set‑up and delivery of global de novo RWE studies. The role can be based in either our Cambridge or London office.

Key responsibilities will include:

• Leading the set‑up and management of RWE studies, including Phase IV, interventional, non‑interventional, observational, and market research studies while deputising for the Study Management Lead as needed.
• Overseeing IRB/IEC submissions, site feasibility assessments, contracting, and local approvals.
• Developing and reviewing essential study documents such as protocols and regulatory submissions.
• Conducting and leading Site Initiation Visits, site meetings, and closure visits; identifying potential study sites and assessing feasibility.
• Serving as the main point of contact for study sites, providing ongoing support and communication throughout the study lifecycle.
• Monitoring study progress, tracking enrolment and milestones, and proactively managing risks and mitigations, including safety management plans and CAPAs.
• Maintaining oversight of study budgets, invoicing, and compliance documentation.
• Collaborating with statisticians and epidemiologists to support data analysis and reporting.
• Contributing to the development and implementation of SOPs, internal training, and process improvements.
• Acting as a strategic advisor on study management, ethics, and compliance across the company.
• Supporting business development efforts, including proposal writing and expanding RWE service offerings.

Flexible working arrangements allow colleagues who have passed probation to work from home for up to half of the time, measured over a 2‑week rolling period. During the probationary period (normally the first 6 months) work from home is permitted for 1 day per week.

To learn more about the personal and professional development opportunities at Costello Medical, explore first‑hand career profiles from our colleagues:
Career Profiles.

Costello Medical is a rapidly growing global healthcare agency specialising in medical communications, market access, and health economic and outcomes research. We work with the industry’s most successful pharmaceutical and medical technology companies, patient and public health bodies, and charitable organisations. We have been listed in the Top 100 Best Companies to Work For list since 2017 and received B Corporation accreditation in 2022.

Essential:

• Minimum 2 years’ experience in a study management or clinical trial/study coordination role.
• Experience working in clinical research across the UK, EU, or the US.
• Degree‑level qualification in a scientific discipline (minimum 2.1 or equivalent).
• Understanding of RWE or clinical research methods and study designs.
• Understanding of regulations and guidelines for clinical research across multiple geographies.
• Exceptional attention to detail and high written accuracy, including proficiency in written English.
• Strong written communication skills and experience creating detailed documents such as SOPs and study protocols.
• Capacity to maintain exceptional customer service and quality of deliverables under multiple competing demands.
• Experience communicating directly with key stakeholders.
• Experience autonomously managing clinical studies or aspects of their delivery.
• Ability to work independently with minimal supervision beyond initial onboarding.

Desired:

• Regulatory compliance experience (e.g., audits, inspections, CAPA planning).
• Experience with Phase IV studies, observational research, and/or NIS.
• Experience conducting clinical research within APAC and/or North America.
• Experience working in a Contract Research Organisation.

• Salary of £50,000 to £55,000 per annum, plus discretionary profit share bonus paid twice per year.
• 25 days’ annual leave plus bank and public holidays, with a holiday buy‑and‑sell scheme.
• Flexible working hours and the chance to work from home for up to half of working time after probation.
• Flexible benefits scheme offering cash…