Consultant – Clinical Outcome Assessments

Job title:

Consultant – Clinical Outcome Assessments

Company

Clarivate

Job description

We are looking for a UK (London) based Consultant (Clinical Outcome Assessment – COA) 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 primarily focused in two high-growth areas of the consulting business; Clinical Outcome assessment:

• Contribute to projects focused on the development, evaluation, and implementation of Clinical Outcome Assessments research including Patient Reported Outcomes.
• Provide research support 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 to 6 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, MAXQDA), qualitative research methods, and literature review methods.

Preferred Qualifications:

• A PhD or PostDoc 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 and project manage small to medium-sized COA projects to select, develop, and validate Clinical Outcomes Assessments (including Patient Reported Outcome measures) for use in clinical trials, in line with regulatory guidance (e.g., FDA PRO Guidance for Industry, FDA Patient-Focused Drug Development Guidance).
• Develop study protocols, interview guides, and surveys.
• Conduct qualitative interviews using concept elicitation and cognitive debriefing methodology, and lead coding and qualitative analysis.
• Conduct literature and COA instrument reviews.
• Write scientific reports, manuscripts, and abstracts.
• Manage COA Associates and provide technical domain training and guidance in US and EU regulatory guidance for PRO/COA endpoints, qualitative, quantitative, and mixed methods research methods and analysis within a COA context, literature and instrument reviews, clinical trial endpoint reviews, and development and validation of PRO endpoints for product labeling claims and facilitating market access.
• Contribute to the attainment of yearly revenue/profit targets, business development, and proposal writing.
• Project management for clinical outcomes assessment projects, including targeted literature reviews, qualitative interview studies, quantitative studies, COA landscaping, and strategy projects.

About the Team:Our team consists of 25+ outcomes researchers who have extensive methodological and commercial experience. We are experienced in the design, validation, and implementation of Patient-Reported Outcomes (PRO) and other COA instruments for clinical trials and clinical practice, with a focus on FDA, EMA, and HTA bodies. We have significant experience across a range of therapy areas, such as oncology, immune disorders, respiratory, psychiatry, CNS, autoimmune, infectious diseases, pain, and women’s health. Supported by a global multi-disciplinary team from the wider Clarivate team, we can involve medical writers, health economists, systematic reviewers, and strategic advisors in our projects as needed. Together, our experts provide integrated health economics and outcomes research (HEOR) and market access solutions across the product life cycle.Hours of Work:This is a full-time permanent position based in London, UK, and will require hybrid working in our Liverpool Street office (2-3 days per week in the office, rest of the week remote). This position requires weekday (Monday – Friday) attendance with some scheduling flexibility available around core working hours.Our UK Employee Benefits Include:

• Private Medical Insurance or Health Cash Plan
• Generous Pension Plan contribution rates
• Income protection insurance
• Life insurance
• Sports Club Subsidy (Company pays 50% of gym membership, or up to £500)
• Emergency Childcare or Adult care cover
• Eyecare vouchers
• From 25 Days Annual Leave + 8 Bank Holidays (option to buy and sell Annual leave)

#LI-Hybrid, #LI-Onsite, #LI-SK1At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.

Expected salary

Location

London

Job date

Sun, 09 Feb 2025 23:12:44 GMT

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