Senior Study Management Specialist

Costello Medical•Boston, MA

21h•$95,000 - $105,000•Hybrid

About The Position

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.

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

Nice To Haves

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

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

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
23 days’ vacation leave increasing by 1 day each year to a maximum of 27 days
6 public holidays plus 1 floating vacation day to use on a holiday of your choosing
Flexible working hours and the chance to work from home for up to half of your working time
Private medical insurance with a company contribution, as well as dental and vision cover, and life insurance
Retirement savings via a 401k plan with up to a 5% employer match
Paid funding for external education, and study leave
Paid sabbaticals based on length of service
Regular company-funded social activities