Job Description

New Job - Research Analyst (Patient Recorded Outcomes)

• up to \xc2\xa369.13p/h PAYE or \xc2\xa390.49 p/h umbrella (inside IR35) * equivalent of up to \xc2\xa3135k per annum.
• Temporary
• Central London, Greater London, Rest of the UK
• Ref: 22191

Your New Job Title: Research Analyst (Patient Recorded Outcomes)

Your New Daily rate: up to \xc2\xa369.13p/h PAYE or \xc2\xa390.49 p/h umbrella (inside IR35) * equivalent of up to \xc2\xa3135k per annum.
Duration: Long Term Temporary 12-month Maternity Cover
Location: Remote Role
Start date: ASAP
Working hours: 37.5 hours per week
Job posting ID: JP100588

Who you\'ll be working for: Our client, a major FTSE100 business, are looking for a Research Analyst (Patient Recorded Outcomes).

What you\'ll be doing each day:

The Patient Centred Outcomes Team for Speciality Drugs maintains a sharp focus on the value of patient-centric outcomes across the entire speciality care and general medicines portfolio. We want to ensure that each clinical program has a well-characterized, innovative Patient Recorded Outcome/Clinical Outcome Assessments strategy that is defined early in the development lifecycle and has clear plans to develop evidence that supports PRO/COA-related endpoints.

• Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across the company\'s speciality and primary care portfolio (with opportunities in oncology medicine and vaccines)
• Guide the development, validation, analysis, interpretation, and utilization of PRO/COA instruments in the context of clinical trials and/or observational studies
• Work cross-functionally (e.g., clinical operations, biostats teams) to ensure the value of patient-centric endpoints is communicated clearly and that PRO/COAs are implemented and analysed appropriately in clinical trials (and are accurately described in statistical analysis plans, study reports and publications)
• Support key communications with regulatory bodies by developing targeted questions related to the PRO/COA endpoint strategy and identifying the critical evidence needed for meetings to support the company\'s patient-centric endpoint strategies
• Support broader publication strategy by planning for and contributing to external publications (e.g., scientific abstracts and peer-reviewed manuscripts) which present PRO-related results from clinical trials and/or PRO development and validation studies
• Maintain awareness of scientific and regulatory changes across the company\'s speciality and primary care drug development programs
• Pursue ongoing learning to understand and adopt evolving methodologies and guidelines (including those from regulatory authorities) and communicate findings to Variable Evidence Outcomes and functional groups as needed.

The skills you need to succeed:

• Experience with planning and managing PRO development and validation projects for drug development in in a consulting and/or pharmaceutical company environment.
• Clear understanding of the FDA Patient Reported Outcomes Guidance
• Experience in pharmaceuticals, particularly in drug and vaccine development, with demonstrated experience in clinical trial planning and execution
• Strong background in statistical methods for the evaluation of PROs/COA endpoints.
• Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data in drug and vaccine development.
• Understanding of the evolving methods and regulatory environment with respect patient-reported outcomes (PRO) and clinical outcome assessments (COA)
• Strong verbal and written communication skills, with stakeholder engagement from operations through executive levels
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Ideally Master\xe2\x80\x99s or Doctoral degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Public Health, Epidemiology, Pharmacy, or a closely related discipline

*Please note this Umbrella rate is the amount payable to Umbrella company - this does not represent what you will actually receive from the Umbrella company

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We would be grateful if you could send your CV as a Word document. If your application is successful, you will be contacted within 7 days. We regret that due to the high volume of applications we receive we cannot provide feedback on individual CVs. Please note that we can only consider candidates who are eligible to work in the UK and are able to provide relevant supporting documentation.

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