Study Management Coordinator

Role Summary

• Responsibilities : You will assist on a range of projects involving the set-up and management of de novo real-world evidence (RWE) studies across the world, including ethics applications and site support
• Salary : £35,000 per annum
• Benefits : Discretionary profit share bonuses, hybrid working options that allow you to work from home up to 50% of your time after passing probation, generous holiday allowance, flexible working hours, employer pension contributions, comprehensive travel insurance, private medical insurance, critical illness cover, income protection, full funding for external training, interest-free travel loan scheme, discounted gym memberships, and more
• Role Type : Full-time, permanent
• Start Date : We are currently recruiting for start dates in early 2025, including February and March, and you will be asked to state your availability on your application form
• Location : This role is available in our Global Headquarters in Cambridge , as well as our London office

About the Role

We have an exciting and unique opportunity for a clinical research professional to join the RWE team at Costello Medical , where development of our RWE services is a key strategic priority. In this role, you will have a wealth of opportunities to support the Study Management Lead, as well as to play a key role in our RWE team.

Costello Medical is looking to expand its services related to the set-up and management of de novo RWE studies across our office locations. We are looking for an entrepreneurial individual who can work closely with the Study Management Lead to support with the development and growth of our capabilities in study set-up, including, but not limited to, ethics applications and site support.

Whilst this role will be based in either our Cambridge or London offices, there will be plenty of opportunities for truly global collaboration with the wider RWE team who are based across all our offices.

Key responsibilities will include:

1. Project Management and Client Support:

• Supporting the Study Management Lead with the design, execution, and reporting of RWE studies ensuring alignment with strategic objectives and client expectations
• Supporting with the development of Institutional Review Board (IRB)/Independent Ethics Committee (IEC) applications and other regulatory documents preparation for applicable RWE projects in line with applicable local laws. This includes coordinating the assembly of submission packets, responding to ethics queries and close collaboration with study sponsors and the project team
• Supporting on client accounts and projects, which will involve set-up and management of RWE studies, and responsibility for aspects of their successful delivery
• Ensuring you stay up to date with the latest, relevant regulations and guidelines surrounding clinical research and assisting the Study Management Lead with disseminating this knowledge
• Managing project timelines, resources, and deliverables to ensure high-quality and timely completion of projects
• Overseeing data collection, entry, and management for assigned studies, ensuring accuracy and completeness
• Collaborating with Statisticians and Analysts to perform data analysis and prepare comprehensive reports of study findings as needed
• Identifying and coordinating with clinical research sites, ensuring all necessary infrastructure and protocols are in place for the study
• Facilitating smooth setup and offering ongoing support for the duration of the study

2. RWE Capability Development and Strategy:

• Assisting the Study Management Lead with delivery of a strategy to increase our capabilities, grow our pipeline and build our external reputation in the field of RWE
• Collaborating effectively with the Study Management Lead and wider company to develop our capabilities in RWE

Hybrid Working Policy: We recognise that home-working can improve work life balance, reduce commuting times and costs, and provide the opportunity to juggle personal commitments. At the same time, 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.

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 Profile

We offer many opportunities for personal and professional development at Costello Medical. Please click below to read firsthand accounts from our colleagues about their time with the company: https://www.costellomedical.com/careers/working-at-costello-medical/

Requirements

About You

This is a fantastic opportunity for a clinical research professional to utilise their 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 the company, 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 with 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 1 year of experience in study management, clinical trial/study coordination, regulatory compliance or clinical data management
• 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). We welcome applications from candidates with a diverse range of specialisms, including but not limited to; biology, life science, epidemiology, biostatistics, and public health
• 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 high degree of written accuracy, as well as excellent proficiency in written English
• The capacity to maintain exceptional customer service and quality of deliverables under multiple competing demands
• Experience in communicating directly with key stakeholders
• The self-awareness to reflect on your own work and performance, alongside a willingness to take ownership of your work and the development of your career

Desirable requirements for the role are:

• Experience in the Asia-Pacific (APAC) region
• Experience within a contract research organisation

Benefits

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. Our mission is to be a community of the very best people, building trusted partnerships across the healthcare sector by delivering an exceptional service. Our vision is to be a leading global partner consistently striving for meaningful and outstanding contributions that improve people's health and lives.

We are committed to our company values which are central to creating our fun, friendly and innovative workplace in which we strive to deliver the highest standards of quality. As a result, we have been listed in The Top 100 Companies to Work For list for seven consecutive years.

On 27th May 2022, Costello Medical received its certification as a B Corporation . We are really proud of this achievement as it demonstrates that Costello Medical is meeting the highest standards of verified social and environmental performance. We ...