Associate Principal Scientist

Clinical Project Manager/Scientist

North Wales, PA, US

Pay Rate Low: 58.68 | Pay Rate High: 58.68

• Added - 13/05/2024

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Type: Contract (2 years)

Location: North Wales, PA (Hybrid)

Pay: $58.68/hr

Responsibilities:

• 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.

INDBH

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.