Senior Study Management Coordinator

Costello Medical; City of Westminster; Hybrid; GBP 45,000 - 60,000; Full time

Job summary

A global healthcare agency in the UK seeks an experienced clinical research professional to lead real-world evidence studies. The role includes managing study activities and ensuring compliance with ethical standards. Candidates should have a scientific degree, at least 2 years of experience in study management, and strong communication skills. Flexible working arrangements and a comprehensive benefits package are offered.

Benefits

Discretionary profit share bonuses

Private medical insurance

Funding for external training

Flexible working options

Qualifications

• Minimum 2 years' experience in study management or clinical trial coordination.
• Experience in clinical research across the UK, EU or the US.
• Understanding of RWE or clinical research methods.

Responsibilities

• Lead setup and management of RWE studies.
• Oversee IRB/IEC submissions and local approvals.
• Develop and review essential study documents.

Skills

Study management

Clinical trial coordination

Attention to detail

Written communication

Stakeholder communication

Education

Degree in a scientific discipline

Job description

Overview

We are seeking an experienced clinical research professional to join the team at Costello Medical. Based within our Study Management sub-team, which leads the setup and delivery of global de novo real-world evidence (RWE) studies, the role can be based in either our Cambridge or London office, with opportunities for extensive collaboration across our international team. As a senior member of the team, you will independently manage study and site activities across a portfolio of projects and act as the primary contact for study management tasks, providing strategic leadership and ensuring high-quality delivery in line with ethical and regulatory standards.

This role offers the chance to shape the future of RWE delivery at Costello Medical, contribute to the development of best practices, and work on impactful global studies.

Responsibilities

• Leading the setup 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 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions, site feasibility assessments, contracting, and local approvals
• Developing and reviewing essential study documents, including protocols and regulatory submissions
• Conducting and leading Site Initiation Visits (SIVs), 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 with responsibility for escalation of concerns, safety management plans, risk-based quality management, and CAPAs
• Maintaining oversight of study budgets, invoicing, and compliance documentation (e.g. Study Master File/Trial Master File)
• 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, ensuring adherence to best practices and industry standards
• Supporting business development efforts, including proposal writing and expanding RWE service offerings, while contributing to pipeline growth and expansion of UK RWE team capabilities

Hybrid Working Policy

We offer flexible working arrangements that allow our colleagues who have passed probation to work from home for up to half of the time, measured across a 2-week rolling period. During your probationary period (normally the first 6 months of the role) you will be able to work from home for 1 day per week.

About Costello Medical

Costello Medical is a rapidly growing global healthcare agency specialising in medical communications, market access, and health economic and outcomes research. We work with a wide range of clients, including pharmaceutical and medical technology companies, patient and public health bodies, and charitable organisations. We have been listed since 2017 and were proud to receive accreditation in 2022. Please note that, whilst we embrace AI to innovate and improve processes, your role may involve confidential data that cannot be uploaded to AI.

Requirements

This is a fantastic opportunity for a clinical research professional to utilise a range of skills in a role that requires a passion for real-world evidence studies, paired with excellent organisational skills. Essential requirements for the role are:

• A minimum of 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
• A degree level qualification in a scientific discipline (minimum 2.1 or equivalent)
• An understanding of RWE or clinical research methods and study designs
• An understanding of the regulations and guidelines for clinical research across multiple geographies
• An exceptional level of attention to detail and a high degree of written accuracy, as well as excellent proficiency in written English and arithmetic
• Strong written communication skills, with experience of creating detailed documents related to clinical study operations, such as SOPs, study protocols and other essential study documents
• The 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
• The ability to work independently and take initiative, with minimal supervision required beyond initial onboarding

Desirable

• Regulatory compliance experience (audits/inspections, CAPA, or regulatory/quality roles)
• 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

Role Details

• Role Type: Full-time, permanent
• Start Date: We are currently recruiting for start dates throughout 2025, including October and November; you will be asked to state availability on your application
• Location: Cambridge or London
• Application Deadlines: There are no set deadlines; the role will close when a suitable candidate is found

Benefits

• Discretionary profit share bonuses paid twice per year
• Hybrid and flexible working options, generous holiday allowance, private medical insurance, critical illness cover, income protection, full funding for external training
• Additional benefits: paid study leave and funding for external qualifications, pension contributions, life assurance, and sabbaticals based on length of service