Associate Principal ScientistClinical Project Manager/ScientistNorth Wales, PA, USPay Rate Low: 58.68 | Pay Rate High: 58.68
Added - 13/05/2024
Apply for JobType: Contract (2 years)Location: North Wales, PA (Hybrid)Pay: $58.68/hrResponsibilities:
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 Merck 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 (+3 yrs), MS (+5 yrs), or BS (+10 yrs) in Health Services Research, Statistics, Psychometrics, Outcomes Research (or closely related field) with relevant industry work experience in the COA field
Familiar with COA/PRO requirements for regulatory and reimbursement agencie
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 skill
Experience with COA/PRO-related scientific presentations and publications.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.