Study Management Lead (Real-World Evidence)

Job ID:

566f326

Location:

Manchester, England

Published:

1 day ago

Salary 47000 GBP

Company

Costello Medical

Website

www.costellomedical.com

Headquarters

Cambridge, United Kingdom

CEO

Sophie Costello

Revenue

Unknown / Non-Applicable

Type

Company - Private

Sector

Pharmaceutical & Biotechnology

Founded

2008

Job Description

About the Role

We have an exciting and unique opportunity for an experienced professional within the real-world evidence(RWE) space to join 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 at a senior level, in a role that will provide them with a wealth of opportunities to contribute to the strategy and direction of our RWE team.

We are seeing an unprecedented level of growth in the demand for RWE, which is increasingly being used to inform decision-making across the world. Costello Medical is looking to expand its services related to the set-up and management of de novo RWE studies across the world. We are looking for an experienced and entrepreneurial individual who can drive forwards and grow our capabilities in study set-up, including, but not limited to, ethics applications and site support.

Considering the points of overlap between RWE and Market Research studies, it is anticipated that you will also play a part in the delivery and development of our Market Research services.

Learn more about our RWE team here: https://www.costellomedical.com/what-we-do/evidence-development/real-world-evidence/

Whilst this role will be based in one of our UK offices, there will be plenty of opportunities for truly global collaboration with the wider RWE team who are based across all our offices. In the future, relocation opportunities are likely to be available for those interested in working and living abroad.

Key responsibilities will include:

Independently managing client accounts and projects which will involve set-up and management of RWE studies, and responsibility for their successful delivery
Supporting and advising other project managers to scope, plan and manage aspects of their projects related to the set-up and management of RWE and Market Research studies
Oversee Institutional Review Board (IRB)/Independent Ethics Committee (IEC) applications and amendments for applicable RWE projects. This includes coordinating the assembly of submission packets, responding to Ethics queries and close collaboration with study Sponsors in line with applicable local laws, through to approval
Constructively reviewing and appraising Costello Medical’s experience in the set-up and management of RWE studies to identify and address strengths, weaknesses, opportunities and threats
Determining and executing, in collaboration with senior colleagues, a strategy to increase our capabilities, grow our pipeline and build our external reputation in the field of RWE
Advising clients and internal members of the project team to ensure that best practices and industry standards are adhered to, including completing and advising on external trainings to ensure Costello Medical’s compliance with the latest best practice
Creating and delivering internal training to support others in developing their expertise in RWE and Market Research studies
Driving business development, both within and outside of current service offerings. This will include identifying opportunities for future projects and maintaining excellent relationships with all clients, with a focus on growing the volume of work delivered within the UK RWE division
Helping to maintain the positive, friendly and collaborative environment within the company
Contributing to the wider aims of the company wherever possible and aligned to individual interests
Acting as a role model for colleagues, exemplifying the mindsets and approaches expected of all colleagues
Collaborating effectively with the Operations division, notably the Legal and Finance teams, to develop our capabilities in RWE
Line management, which will include responsibility for ensuring employees’ job satisfaction and wellbeing at work. You will support your direct reports with workload management and their personal career development by providing regular contact, performance reviews and ongoing constructive feedback
Providing mentorship, leadership and training for junior colleagues within the RWE division and across the wider company

Our standard working week is 37.5 hours, Monday to Friday, however we can also consider applicants looking for part-time hours of 22.5 hours (3 days) per week.

About You

This is a fantastic opportunity for an established Clinical Research professional to utilise a range of skills in a role that combines a passion for real-world evidence study with an entrepreneurial flair. As this is a priority growth area for the company, there is an opportunity for the successful candidate to establish themselves as a thought leader from the outset, and drive the establishment and expansion of RWE studies within Costello Medical.

We are looking for individuals who are collaborative, self-motivated and enthusiastic with a strong and demonstrable background within the healthcare industry and/or pharmaceutical research, with a focus on real-world data.

As we are looking to expand our services in this new area of RWE, it is crucial that this individual is entrepreneurial and able to drive forwards and grow our capabilities.

You will take pride in producing exceptionally high-quality work and will relish the opportunity to build successful client relationships. 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 5 years’ experience in study management, with at least 2 years’ of experience leading the successful execution of RWE studies, specifically relating to study set-up, ethical approval, and study-site support
Experience working across UK or US markets, however experience across additional markets would be beneficial
Experience of managing clinical research studies through their full lifecycle, from start-up through to close-out
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
A comprehensive understanding of RWE research methods and study designs, as well as the ability to train others on these topics
Experience with formally line managing or informally mentoring junior colleagues and supporting with their learning and development
Sufficient technical and strategic knowledge to provide clients with recommendations on project content and approach
An exceptional level of attention to detail and high degree of written accuracy, as well as excellent proficiency in written English and arithmetic
Project management skills sufficient to enable timely project delivery
Strong scientific writing skills with the ability to tailor writing style to different audiences
The capacity to maintain exceptional customer service and quality of deliverables under multiple competing demands
Experience in communicating directly with clients, including responding to different communication styles, as well as a proven ability to build robust and sustainable client relationships

Please note that, as this is a new role for Costello Medical, we are open to speaking to candidates with slightly less experience than has been listed above. If you are someone who is interested in working towards this new role over the next few years, and are willing to develop your skills and experience to meet these requirements in the future, we will provide you with the support needed to reach this. We would therefore still encourage you to apply for the role and we can discuss your suitability in more depth. Please note that this may involve stepping in to a more junior role in the interim, before progressing to the position of Study Management Lead.

The Recruitment Process

Our recruitment process includes a written assessment for you to complete in your own time. If successful, you will be invited to an interview which will include a short presentation you can prepare for in advance.

We are currently recruiting for start dates throughout 2023, including September and October. 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 may close when suitable candidates are found.

Please note that this role is available in our Global Headquarters in Cambridge as well as our London and Manchester offices and our newly opened Bristol office. You can learn more about our office locations here: www.costellomedical.com/careers/locations

What We Offer

A starting salary of £47,000 per annum. Salary increases are awarded annually, with discretionary cash bonuses 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
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 membership
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/working-at-costello-medical/benefits-package-in-the-uk/

Visa Sponsorship

We can provide visa sponsorship for eligible candidates for our Study Management Lead 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.

Job Types: Full-time, Part-time, Permanent
Part-time hours: 30-37.5 per week

Salary: From £47,000.00 per year

Benefits: