Senior Study Management Coordinator

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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, 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. Given our ethos and focus on entry-level recruitment, this is a rare opportunity for someone to utilise their prior experience to join us in a senior role, in a position that will provide them with a wealth of opportunities to contribute to the direction of 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 support with the development and growth of our capabilities in study set-up, including, but not limited to, ethics applications and site support. As a member of the senior team, you will autonomously provide study and site management on selected projects under the guidance of the Study Management Lead.

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. 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, including completing external trainings to ensure Costello Medical's compliance with the latest best practices

6. Project Leadership:

• Acting as a lead for project-specific study and site management on client accounts and projects, which will involve the setup and management of RWE studies, ensuring their successful delivery and compliance with ethical and regulatory standards

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, focusing on growing the volume of work delivered within the UK RWE division

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

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 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 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 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 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 and arithmetic
• 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

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 underwent a rigorous assessment that covered the whole of our business including employee benefits, charitable giving and sustainability. We believe this certification is external validation of our mission to be a force for good.
The Recruitment Process

Our recruitment process includes a telephone interview with a member of the Talent Acquisition team. If successful, you will be sent a technical and proofreading assessment to complete. If you achieve the set pass mark for both exercises, then you will be invited for an interview with members of our Real-World Evidence 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 click here to read more about this and contact the People Team via recruitment@costellomedical.com should you require reasonable adjustments at any stage.

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. Whilst there are no set application deadlines, we strongly recommend applying as early as possible so that we can begin processing your application. The role will close when a suitable candidate is found.

Please note that this role is available in our Global Headquarters in Cambridge, as well as our London office. You can learn more about our office locations here: www.costellomedical.com/careers/locations
What We Offer

• A starting salary of £45,000 per annum
• A discretionary profit share bonus paid twice per year
• 25 days' annual leave plus bank and public holidays
• The chance to work from home for up to half of your working time after passing probation
• Flexible benefits scheme offering additional holiday, cash payments and pension contributions
• 4% employer pension contributions
• Private Medical Insurance which offers comprehensive cover on a "medical history disregard" basis
• Paid study leave and funding for external qualifications
• Cycle to Work scheme and an interest-free travel loan scheme
• Critical Illness Cover, Income Protection and Life Assurance
• Access to an Employee Assistance Programme
• Discounted gym memberships
• Comprehensive travel insurance
• Flexible working hours
• Regular company-funded social activities

Please click here to learn about our reward package and the other benefits of working for Costello Medical: https://www.costellomedical.com/careers/benefits-package-in-the-uk/
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. Your CV should clearly state the dates of all qualifications and grades achieved where applicable.

While we embrace Artificial Intelligence (AI) technologies to innovate and improve processes, we want to understand your unique skills and experiences throughout the recruitment process. Therefore, if you use AI to assist with your application, we recommend that you do not rely solely on this technology to generate your application materials. As your role may involve developing new written content from scratch and handling confidential data that cannot be uploaded to AI technology, it is important for us to assess your own skills and abilities.

Please contact the Talent Acquisition team at recruitment@costellomedical.com if you have any questions about the role or application process.
Visa Sponsorship

We 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.