Manager, PCOR - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
- 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.
- 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.
- Ability to work collaboratively.
- Strong interpersonal skills with an ability to leverage expertise to understand, respond effectively across stakeholders.
- 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.
Source : Katalyst Healthcares & Life Sciences
