Skills Needed
- Clinical Outcome Assessments (COAs) experience
- Develops research/treatment plans
- Leads development & integration of COA measurement strategy
- Identifies & evaluates existing COA tools
Job Description
- The Manager, Patient Experience Data & Strategy role within the Patient-Centered Outcomes Research (PCOR) team works independently while under the supervision of a Director to design and execute patient experience data (PED) evidence research to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (e.g., Clinical Development & Operations, Regulatory, Commercial).
- He/She develops research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple products / indications.
- This research includes literature and landscape reviews, the development and validation of Clinical Outcome Assessments (COAs), and analyses of COA endpoints.
- In addition, he/she supports integration of COA measurement strategies into clinical development programs and develops high-quality documentation to summarize PED for communication in regulatory submissions.
- He/She presents research findings internally to stakeholders within Client and externally. In addition, the Manager builds research relationships with key external thought leaders, fostering industry research collaboration.
Responsibilities Required
- Conducts literature & landscape reviews to identify concepts of importance to patients to develop disease conceptual models
- Identifies & evaluates existing COA tools to determine the extent to which the assessments are fit-for-purpose
- Leads development & integration of COA measurement strategy into clinical development programs through clinical trial program support (e.g., protocol/SAP content development, results interpretation and CSR development) and ensures appropriate implementation of COAs on eCOA platforms in global programs
- Leads design and execution of qualitative research, psychometric analyses, and development of new COA tools
- Contributes to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints
- Develops strategic scientific communication plan including submission and presentation of research in peer-reviewed journals and at medical / methodological congresses
- Contributes to development of PED standards/best practices and educational resources for functions across Client to drive the integration of patient voice in development programs
- Develops and manages publication creation, review / approval, submission and presentation of research in peer-reviewed journals and at medical / methodological congresses
Qualifications
- Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
- Professional experience and training preferred (minimum 2 years of research experience) required. Work experience can include fellowship experience)
- Firm understanding of the scientific fundamentals of COA research & measurement science
- Demonstrated ability to manage multiple projects involving complex processes, significant budget, competing deadlines and rapidly shifting priorities
- Strong written and verbal communication skills
- Experience in handling delivery of services across complex environments
- Experience in managing projects from design through execution
- Some experience / knowledge of the pharmaceutical industry (knowledge of regulatory/compliance frameworks) and clinical trial design
- Demonstrated initiative and strong work ethic
- Willingness to travel as required
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity,
national origin, disability, or status as a protected veteran.
