Senior Study Management Specialist

Global Real-World Evidence Study Manager

You will work on a range of projects involving the set-up and management of global real-world evidence (RWE) studies, including ethics applications and site support.

Salary: $95,000 - $105,000 per annum, depending on your previous experience.

Benefits:
Discretionary profit share bonuses paid twice per year, hybrid and flexible working options, generous vacation allowance, private medical and dental insurance, 401K plan with up to a 5% employer contribution, life insurance, full funding and study leave for external training and more.

Role Type:
Full-time, permanent.

Start Date:

We are currently recruiting for start dates throughout 2026, and you will be asked to state your availability on your application form.

Final date to receive applicationss:
While there are no set Final date to receive applicationss, we strongly recommend applying as early as possible. The role will close when a suitable candidate is found.

Location:

This role is available in our Boston and New York offices, with a preference for Boston as that is where most of the team is based.

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.

Key responsibilities will include:

• 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