Senior Study Management Specialist

Role 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. 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 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 About Costello Medical Costello Medical is a rapidly growing global healthcare agency specialising in medical communications, market access, and health economic and outcomes research. We work with a wide range of clients, including the industry\'s most successful pharmaceutical and medical technology companies, patient and public health bodies, and charitable organisations. We have been listed in the Top 100 Best Companies to Work For list since 2017 and were proud to receive B Corporation accreditation in 2022. Learn more about us, our work, and our mission on our website: Requirements About You This is a fantastic opportunity for a clinical research professional to utilize a range of skills in a role that requires a passion for real-world evidence studies, paired with excellent organizational skills. As this is a priority growth area for Costello Medical, there is an opportunity for the successful candidate to develop quickly with the company. You will take pride in producing exceptionally high-quality work and will relish the opportunity to build successful relationships with clients, as well as internal colleagues. You will identify and capitalise on opportunities to go above and beyond for clients and exceed their expectations wherever possible. Essential requirements for the role are: 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 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 What We Offer $95,000 - $105,000 per annum, depending on your previous experience, as well as a discretionary profit share bonus paid twice per year. Please note that we have established salary bands that ensure a fair and consistent approach for all applicants, eliminating the need for individual negotiations 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 Please click here to learn about our full reward package and the other benefits of working for Costello Medical: Hybrid Working Policy We believe that having face-to-face time in the office holds many benefits and is central to ensuring that the community we have created, where people have a workplace they belong to and feel part of, is never lost. At the same time, we recognize that homeworking can improve work life balance, reduce commuting times and costs, and provide the opportunity to juggle personal commitments. Therefore, we offer flexible working arrangements that allow our colleagues to work from home for up to half of the time, measured across a 2-week rolling period. The Application Process Please note that, while we embrace AI to innovate and improve processes, your role may involve confidential data that cannot be uploaded to AI. Therefore, it is important for us to assess your own skills and abilities, so we recommend that you do not rely solely on this technology to generate any application materials. Visa Sponsorship We welcome applications from international candidates, but we cannot provide visa sponsorship for working visas. Therefore, you must have the right to work in the US independently from the company. However, we do consider those on a temporary visa, such as an OPT visa. #J-18808-Ljbffr Costello Medical