- 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
- 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.
- Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal Scientist has responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for specific disease areas.
- The individual will support teams on the development, validation, analysis, and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.
- The Associate Principal Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.
- 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.
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Associate Principal Scientist - West Point, United States - Experis
Description
Job Title:
Associate Principal Scientist
Department:
Patient-Centered Endpoints & Strategy (PaCES)
Location:
West Point, PA /Rahway, NJ (possibly)
Hybrid: 3 days onsite between Monday- thursday
Shift:
M-F 8:00am - 5:00pm
Pay rate:
$70
Candidate must have the experience with Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs).
Education:
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.
Required Experience:
Software:
MS office suite
Responsibilities:
Primary activities include but are not limited to:
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity.
We look forward to speaking with youAbout ManpowerGroup, Parent Company of:
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup (
NYSE:
MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win.
We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills.
Our expert family of brands –
Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years.
We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
