Senior Study Management Specialist

About the role

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.

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
• 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

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
• The ability to work independently and take initiative, with minimal supervision required beyond initial onboarding

Qualifications

Essential requirements for the role are:

• 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
• The ability to work independently and take initiative, with minimal supervision required beyond initial onboarding

Skills

Desired requirements for the role are:

• 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

• $95,000 - $105,000 per annum, depending on your previous experience, as well as a discretionary profit share bonus paid twice per year
• 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
• Lifetime funding and study leave for external training and more

Pay

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

Schedule

Hybrid and flexible working options