Clinical Research Associate Jobs

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Provide study and operational support to HEOR V&E with a focus on IDM. Assist study lead(s) in the end-to-end process of an HEOR project or ancillary activities. This includes preparing study information and materials (eg, study protocols, project memo, manuscript outlines) in accordance with corporate policies and requirements, vendor management, interactions with external thought leaders, development of presentations/reports & publication support, identification of publications, informal literature searches.

Responsibilities

• Under the guidance of a senior leader, a Research Associate has primary responsibility for planning/managing real world and economic evidence activities for in-line products to meet the value evidence needs of clinicians, payers, policymakers, HTA/reimbursement agencies, and health systems globally

• Types of studies executed include prospective and retrospective observational studies to characterize disease burden and epidemiology, treatment patterns, healthcare resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses, and economic modelling

• The incumbent is expected to work cross-functionally with clinical development, medical affairs, biostatistics, market access, commercial and country affiliates

• The incumbent may supervise external vendors or partners to execute these activities

• The incumbent may have direct interactions with health technology assessment (HTA) agencies, reimbursement decision makers, or national immunization technical advisory groups

• Participate in value evidence teams and serves as outcomes research representative on cross-functional regional and global teams

• Critically assess drivers and barriers to reimbursement and market access, and provide input into clinical, regulatory, payer/access, marketing and evidence generation strategy and programs

• In collaboration with internal teams and external partners, design studies, author study protocols, develop measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications

• Responsible for study-related contracting, budgets, and vendor/partner management

• Develop supplementary clinical data package in close partnership with markets and HTA statistics group for submission to HTA agencies

• Support country affiliates to understand local evidence generation needs, adapt health economic evaluations, customize outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements

• Work closely with cross functional teams to effectively communicate outcomes research and health economic modelling data internally and to external customers

• Maintain awareness of new scientific and methodological developments within therapeutic area

• Present outcomes research data at national and international congresses and publish articles in scientific journals.

Skills:

- Must have: highly detail-oriented, takes a structured and organized approach to work, excellent communication skills, experience in conducting health outcome researches, either in industry or academic settings with an understanding of targeted and systematic literature reviews.

- 3-5 years HEOR modeling experience

- Nice to have: infectious disease experience (theory and/or practice), practical experience with retrospective or prospective Outcomes Research studies.