Senior Study Management Specialist
$95,000–$105,000 year
On-siteNew York City, New York, United States or Boston, Massachusetts, United States
Job Summary
Lead the setup and management of de novo global real-world evidence studies, including ethics applications, site support, and site initiation visits. Oversee Institutional Review Board submissions, contracting, and local approvals while developing and reviewing essential study documents. Monitor study progress, track enrolment, and manage risks through safety plans and corrective actions. Maintain oversight of budgets, invoicing, and compliance documentation. Collaborate with statisticians on data analysis and contribute to standard operating procedures and process improvements. Act as a strategic advisor on ethics and compliance while supporting business development efforts.
Required Qualifications
- 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
- The right to work in the US independently from the company
- 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
Desired Qualifications
- 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
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