Primary Responsibilities/Accountabilities:
- Coordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), Clinical Trial Teams (CTT) and/or Clinical Sub-teams (CST) to assure alignment with product franchise goals.
- Provide assistance on the selection and/or development of COA/PRO instruments for inclusion in studies.
- Provide guidance on implementing COA/PRO instruments into studies by following client's standard processes.
- Facilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs.
- Coordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agencies.
- Coordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studies.
- Conduct literature searches to support COA/PRO endpoint strategies.
- Support/Produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.)
- Keep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed.
Qualifications:
- PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 3+ years of relevant industry work experience in the COA field OR Master's Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 5+ years of relevant industry work experience in the COA field OR Bachelor's degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 10+years of relevant industry work experience in the COA.
- Familiar with COA/PRO requirements for regulatory and reimbursement agencies
- Knowledgeable of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies
- Ability to understand and respond to multiple internal and external customers.
- Strong project management and communication skills
- Experience with COA/PRO-related scientific presentations and publications.
- Software: MS office suite
Preferred:
- Excellent communications skills
- Take the initiative to understand the role.
- Curious about what we do.
- Eager to understand more about this role.
- Adapts well within the group.