Senior Study Management Specialist

Role Summary

We are seeking an experienced clinical research professional to join the RWE team at Costello Medical. In this position, you will be based within our Study Management sub-team, which leads the setup and delivery of global de novo RWE studies. The role can be based in our Boston or New York offices, with a preference for Boston, 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. You will 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.

• Leading the setup and management of RWE studies, including Phase IV, interventional, non-interventional, observational, and market research studies while also 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 alongside 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 Corrective and Preventive Actions (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 standard operating procedures (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 also contributing to pipeline growth and expansion of US RWE team capabilities

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 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 were proud to receive B Corporation accreditation in 2022.

Learn more about us, our work, and our mission on our website:

This is a fantastic opportunity for a clinical research professional to utilize a range of skills in a role that requires a passion for real-world evidence studies, paired with excellent organizational skills. As this is a priority growth area for Costello Medical, there is an opportunity for the successful candidate to develop quickly with the company.

You will take pride in producing exceptionally high-quality work and will relish the opportunity to build successful relationships with clients, as well as internal colleagues. You will identify and capitalise on opportunities to go above and beyond for clients and exceed their expectations wherever possible.

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 within the US
• A degree level qualification in a scientific discipline
• 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 standard operating procedures, 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…