Senior Study Management Coordinator

Costello Medical

  • Cambridge
  • £45,000 per year
  • Permanent
  • Full-time
  • 2 days ago
Job Description:Role Summary
  • Responsibilities: You will work on a range of projects involving the set-up and management of de novo, global real-world evidence (RWE) studies, including ethics applications and site support
  • Salary: £45,000 per annum
  • Benefits: Discretionary profit share bonuses paid twice per year, hybrid and flexible working options, generous holiday allowance, private medical insurance, critical illness cover, income protection, full funding for external training and
  • Role Type: Full-time, permanent
  • Start Date: We are currently recruiting for start dates throughout 2025, including October and November, and you will be asked to state your availability on your application form
  • Application Deadlines: Whilst there are no set application deadlines, we strongly recommend applying as early as possible. The role will close when a suitable candidate is found
  • Location: This role is available in our
, as well as our officeAbout the RoleWe are seeking an experienced clinical research professional to join the 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 either our Cambridge or London office, 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 will include:
  • 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 UK RWE team capabilities
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 recognise 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 who have passed probation to work from home for up to half of the time, measured across a 2-week rolling period. During your probationary period (normally the first 6 months of the role) you will be able to work from home for 1 day per week.Career ProfileTo learn more about the personal and professional development opportunities at Costello Medical, explore first-hand career profiles from our colleagues about their experiences with the company:About Costello MedicalCostello 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 since 2017 and were proud to receive accreditation in 2022. Learn more about us, our work, and our mission on our website:Requirements:About YouThis is a fantastic opportunity for a clinical research professional to utilise a range of skills in a role that requires a passion for real-world evidence studies, paired with excellent organisational 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 across the UK, EU or the US
  • A degree level qualification in a scientific discipline (minimum 2.1 or equivalent)
  • 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
Benefits:What We OfferAlongside our award-winning company culture, where every team member is celebrated, respected, and has their voice heard, we are proud to offer a comprehensive benefits package which includes:
  • A starting salary of £45,000 per annum, as well as a discretionary profit share bonus paid twice per year. Please note that we have established salary bands that ensures a fair and consistent approach for all applicants, eliminating the need for individual negotiations
  • 25 days' annual leave plus bank and public holidays, as well as a holiday buy and sell scheme
  • Flexible working hours and the chance to work from home for up to half of your working time after passing probation
  • Flexible benefits scheme offering cash payments, additional pension contributions and more
  • Private Medical Insurance which offers comprehensive cover on a “medical history disregard” basis
  • Paid study leave and funding for external qualifications
  • Critical Illness Cover, Income Protection and Life Assurance
  • Paid and unpaid sabbaticals based on length of service
Please click here to learn about our full reward package and the other benefits of working for Costello Medical:The Application ProcessYou are required to submit your CV and a cover letter via our online application form. In your cover letter, you must explain why you think you would be suited to the role and why you would like to join Costello Medical, with examples to support both. Your CV should clearly state the dates of all qualifications and grades achieved where applicable.Our recruitment process includes a self-recorded video interview which will be reviewed by the Talent Acquisition team. If successful, you will be sent an assessment to complete from home. If you achieve the pass mark, you will be invited for an interview with members of our RWE team, which will include a short presentation you can prepare for in advance. Our standard recruitment process lasts around one month, however, this can be adapted if necessary.As an equal opportunity employer, we are committed to fostering a diverse and inclusive workforce and, throughout the recruitment process, there are a number of reasonable adjustments we can provide. Please to learn more.Please note that, whilst 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 SponsorshipWe can provide visa sponsorship for eligible candidates for our Senior Study Management Coordinator role. You will be asked to provide details of your right to work in the UK within your application, however this will have no impact on the processing of your application.

Costello Medical