Patient Report Outcomes/Clinical Outcomes Assessment Scientist

Highly Competitive
  1. Contract
  2. Market Access
  3. United States
Cambridge, USA
Posting date: 01 Oct 2024
62535

Patient Report Outcomes/Clinical Outcomes Assessment Scientist - Contract - Remote

Proclinical is seeking a Patient Report Outcomes/Clinical Outcomes Assessment Scientist for a fully remote, 12+ month W-2 contract.

Primary Responsibilities:

The successful candidate will be part of the Patient Centered Outcomes (PCO) team, which is crucial in developing integrated evidence plans to support patient-centric drug development. Your work will ensure that strong PRO/COA strategies are in place to demonstrate the value of our products to patients, physicians, payers, and regulators.

Skills & Requirements:

  • Bachelor's degree required; Master's degree preferred.
  • Relevant experience in the development and implementation of PRO/COA strategies.
  • Strong background in pharmaceutical, regulatory, or academic settings.
  • Excellent cross-functional collaboration skills.
  • Ability to communicate complex scientific concepts clearly.
  • Experience in developing and validating PRO/COA instruments.
  • Knowledge of regulatory guidelines and methodologies.

The Patient Report Outcomes/Clinical Outcomes Assessment Scientist's responsibilities will be:

  • Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across the portfolio.
  • Guide the development, validation, analysis, interpretation, and utilization of PRO/COA instruments in clinical trials and/or observational studies.
  • Collaborate with cross-functional teams (e.g., clinical operations, biostatistics) to ensure clear communication and appropriate implementation of patient-centric endpoints in clinical trials.
  • Support regulatory communications by developing targeted questions and identifying critical evidence for meetings to support patient-centric endpoint strategies.
  • Contribute to the broader publication strategy by planning and contributing to external publications, including scientific abstracts and peer-reviewed manuscripts.
  • Stay informed about scientific and regulatory changes across specialty and primary care drug development programs.
  • Pursue ongoing learning to understand and adopt evolving methodologies and guidelines, and communicate findings to cross-functional groups as needed.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at B.Forsen@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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