Consultant; Clinical Outcome Assessment - COA

Position: Consultant (Clinical Outcome Assessment - COA)
Location: Greater London

## Consultant (Clinical Outcome Assessment - COA)
Apply remote type:
Remote locations:
Remote (242
- England):
UK - London time type:
Full time posted on:
Posted Todayjob requisition :
JREQ
135942

We are looking for a
** Consultant (Clinical Outcome Assessment - COA) - (UK fully Remote or London Hybrid )
** to serve as a critical member of project teams by providing analytical insight, leadership, and creativity to billable client engagements, business development efforts, and internal initiatives.

The Consultant will help define projects, build work plans, and develop robust and valuable conclusions and recommendations for our clients. Consultants are vital to ensuring that we provide our clients with the insights and information they need to achieve success.

This role is focused in a high-growth area of the consulting business; the Clinical Outcome Assessment (COA) Team. You will be expected to:
• Lead projects focused on the development, evaluation, and implementation of COA research including Patient Reported Outcomes (PROs).

• Provide and drive research activities in all aspects of project delivery including qualitative and quantitative data collection, data analysis, report writing, and writing abstracts and manuscripts
** About You – Experience, Education, Skills, and Accomplishments:
*** A Master’s degree in health psychology, psychology, sociology, life sciences, or another relevant topic (a 2:1 or higher).
* 5  years of experience in outcomes research, qualitative research, and/or patient-reported outcomes development and evaluation.
* Proficient with MS Office Suite (PowerPoint, Excel, Word, Outlook, Teams).
* Proficient with qualitative analysis software (e.g., NVIVO, ATLAS, or MAXQDA), qualitative research methods, and literature review methods.
*
* Preferred Qualifications:

*** A PhD or Post Doc research experience.
* Understanding of clinical drug development and regulatory (FDA, EMA) procedures and guidance.
* Knowledge of the pharmaceutical/medical device industry and the clients' operating environment.
** What You Will Be Doing:
*** Lead complex, global COA projects—including the selection, development, and validation of COA instruments such as PRO measures—ensuring alignment with regulatory requirements (e.g., FDA PRO Guidance, EMA, PFDD).
* Provide strategic oversight and scientific direction across multiple concurrent COA engagements, ensuring methodological rigour, high-quality deliverables, and strong client satisfaction.
* Drive strategic input into clinical development programmes by guiding clients on COA strategy, endpoint selection, and evidence generation to support labelling claims and market access.
* Oversee the design and delivery of mixed-methods research, including concept elicitation and cognitive debriefing interviews, quantitative validation studies, and literature/instrument reviews.
* Serve as scientific lead for key client engagements—presenting findings, guiding discussions, and acting as a trusted advisor on COA-related decisions.
* Mentor and line-manage associate consultants and associates, providing training in qualitative and quantitative COA methods, regulatory guidance, and the development of endpoint strategies.
* Collaborate with internal and external stakeholders (biostatistics, regulatory, clinical teams) to integrate COA strategies into broader clinical and commercial objectives.
* Lead business development activities including proposal development, bid defence meetings, and identification of new client opportunities within the COA space.
* Contribute to the evolution of the COA practice through thought leadership (e.g., publications, conference presentations), methodology development, and refinement of internal best practices.
* Support strategic planning and resource management within the practice, helping to shape team structure, resourcing, and future capabilities.
** About the Team:
** Our team consists of 30+ outcomes researchers who have extensive methodological and commercial experience. We are experienced in the design, validation, and implementation of PRO measures and other COA instruments for clinical trials and clinical practice, with a focus on FDA, EMA, and HTA…