Role Summary
- Responsibilities: You will work 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: £45,000 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, andmore.
- 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 ourGlobal Headquarters in Cambridge, as well as ourLondonoffice.
About the Role
We have an exciting opportunity for a clinical research professional to join theRWEteam atCostello Medical, where development of our RWE services is a key strategic priority. This is a rare opportunity for someone to utilise their prior experience to join us in a senior role, providing them with a wealth of opportunities to contribute to the direction of our RWE team.
Key responsibilities will include:
1. Regulatory and Ethics Support:
- Supporting the development of Institutional Review Board (IRB)/Independent Ethics Committee (IEC) applications and other regulatory document preparation for applicable RWE projects in line with local laws.
- Coordinating the assembly of submission packets, responding to ethics queries, and collaborating closely with study sponsors and the project team.
2. Data Management and Analysis:
- 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.
3. Study Site Coordination:
- Identifying and coordinating with clinical research sites, ensuring all necessary infrastructure and protocols are in place for the study.
- Facilitating smooth setup and providing ongoing support throughout the study duration.
4. Strategic Development:
- Contributing to and implementing strategies to increase our capabilities, grow our pipeline, and build our external reputation in the field of RWE.
5. Client and Team Advising:
- Advising clients and internal project team members to ensure adherence to best practices and industry standards.
6. Project Leadership:
- Acting as a lead for project-specific study and site management on client accounts and projects.
7. Internal Training and Development:
- Contributing to internal trainings to support the development of others' expertise in RWE and Market Research studies.
8. Business Development:
- Supporting business development efforts, both within and outside of current service offerings.
9. Company Culture:
- Helping to maintain the positive, friendly, and collaborative environment within the company.
10. Capability Collaboration:
- Collaborating effectively with the Study Management Lead and wider company to enhance our capabilities in RWE.
About You
Essential requirements for the role are:
- A minimum of 2 years’ 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).
- 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.
- The capacity to maintain exceptional customer service and quality of deliverables under multiple competing demands.
- Experience in communicating directly with key stakeholders.
- Experience autonomously managing clinical studies or aspects of their delivery.
Desirable requirements for the role are:
- Regulatory compliance experience.
- Experience in APAC (Asia-Pacific region).
- Experience within a Contract Research Organisation.
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.
How to Apply
You 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.
Please contact the Talent Acquisition team at if you have any questions about the role or application process.
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