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Principal Scientist (Clinical Outcomes Assessment (COA))

Company: Innova Solutions
Location: Lansdale
Posted on: June 10, 2024

Job Description:

Innova Solutions is immediately hiring for an Associate Principal Scientist (Clinical Outcomes Assessment (COA)/Patient-reported outcome (PRO)) Position type: Full-time Contract Duration: 24+ months of contract Location: West Point, PA OR Rahway, NJ (Hybrid) Responsibilities: Responsibilities: 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.Primary activities include but are not limited to:

  • 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 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: Actual Title: Associate Principal Scientist Department- Patient-Centered Endpoints & Strategy (PaCES) Education:
  • 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. Required Experience:
  • 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 Personality:
  • Excellent communications skills Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you!Shakir Ahmed Sr. Recruiter PHONE (208-620-3493) EMAIL () PAY RANGE AND BENEFITS: Pay Range*: Pay Range: $54 - $58 per hour. *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions:
    • One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
    • ClearlyRated - Client Diamond Award Winner (2020)
    • One of the Largest Certified MBE Companies in the NMSDC Network (2022)
    • Advanced Tier Services partner with AWS and Gold with MSWebsite: Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. - 1324b.The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.American Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.

Keywords: Innova Solutions, Philadelphia , Principal Scientist (Clinical Outcomes Assessment (COA)), Healthcare , Lansdale, Pennsylvania

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