Senior Study Management Specialist
Costello Medical
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.
Job description
Key Responsibilities
- 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
Essential Requirements
- 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 onboarding
Desired Requirements
- Regulatory compliance experience, for instance, experience with audits or inspections of clinical research, issue identification or CAPA planning, or having worked in a regulatory or quality role
- Experience specifically with phase IV studies, observational research and/or NIS
- Experience in conducting clinical research within APAC (Asia-Pacific region) and/or North America
- Experience working in a Contract Research Organisation
Requirements
- 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 onboarding
- Regulatory compliance experience, for instance, experience with audits or inspections of clinical research, issue identification or CAPA planning, or having worked in a regulatory or quality role
- Experience specifically with phase IV studies, observational research and/or NIS
- Experience in conducting clinical research within APAC (Asia-Pacific region) and/or North America
- Experience working in a Contract Research Organisation
Benefits
- Discretionary profit share bonuses
- Hybrid and flexible working options
- Generous vacation allowance
- Private medical insurance
- Dental and vision cover
- Life insurance
- 401(k) plan with 5% match
- Paid external training funding
- Study leave
- Paid sabbaticals
- Company-funded social activities
Company overview
Costello Medical is a leading global healthcare consulting firm specializing in scientific support services for the pharmaceutical, biotechnology, and medical device industries. Founded in 2008 and headquartered in Cambridge, UK, the company has grown organically to over 500 employees across nine international offices including the UK, US, Singapore, and China. The firm provides comprehensive services including evidence development, health economics, market access, health technology assessment (HTA), medical communications, real-world evidence analysis, and statistical modeling. Costello Medical supports healthcare interventions throughout their entire lifecycle, working with leading pharmaceutical and device companies across diverse therapy areas and geographies. The company is a certified B Corporation, demonstrating its commitment to high standards of social and environmental performance, and has achieved 3-star accreditation with Best Companies for six consecutive years. Their expertise spans infectious disease modeling, rare diseases, gene therapy, and technical innovation with AI applications.