Epidemiologist III - Pharmaceutical / Clinical Tri

Company: Collabera
Location: Rahway
Posted on: February 19, 2025

Job Description:

Key Responsibilities:

Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.
Clinical Outcome Assessments (COA):

Provide expertise in patient-reported outcomes (PRO), clinician-reported outcomes, and COA endpoint development.
Lead and guide endpoint development strategies for clinical trials.
Support regulatory interactions by ensuring compliance with current regulatory requirements for patient-reported outcomes.



Clinical Trials & Study Support:

Collaborate with clinical study teams throughout early to late-stage drug development.
Conduct literature searches to inform COA endpoints.
Participate in clinical trial protocol development and COA implementation.
Lead non-interventional studies to validate COA measurement instruments.
Interpret data and contribute to clinical study reports.



Cross-Functional Collaboration & Leadership:

Work with regulatory agencies and reimbursement teams (HTA - Health Technology Assessment).
Integrate within multi-disciplinary teams including Value Evidence Teams and other strategic groups.
Take ownership of assigned projects, ensuring proactivity and responsiveness in communication.


Must-Have Experience:

Industry experience in pharmaceutical or drug development (academic backgrounds alone are not sufficient).
Strong knowledge of regulatory guidelines for patient-reported outcomes.
Clinical trial experience is mandatory (observational study experience is a plus but not a substitute).
Demonstrated ability to lead and contribute to COA endpoint development.

Preferred Experience:

Experience working in a COA group within a pharmaceutical company.
Familiarity with non-interventional and real-world evidence studies.
Prior collaboration with regulatory and reimbursement agencies.


Pay Range:
$60 - $70/hr.

Keywords: Collabera, New York , Epidemiologist III - Pharmaceutical / Clinical Tri, Healthcare , Rahway, New York