Senior Associate, eCOA Manager overseeing Electronic Clinical Outcome Assessment technologies in pharmaceutical development. Engaging with clinical teams and stakeholders to implement eCOA strategies efficiently and effectively.
Responsibilities
Assisting in the implementation and management of Electronic Clinical Outcome Assessment (eCOA) and other related Patient technologies throughout Pfizer Research & Development
Working as a member of the Patient Data Strategies (PDS) team to help clinical study teams use assigned patient data technologies
Taking ownership of sub-projects within the overall initiative
Engaging a variety of stakeholders and customer groups to ensure study teams are enabled to implement eCOA in clinical studies efficiently, consistently and with the highest quality and lowest regulatory risk
Considering technologies allied and parallel to eCOA
Requirements
Bachelor’s degree or equivalent in a scientific discipline required
Master’s degree in Statistics, Computer Science or related field or equivalent experience preferred
Minimum 3-5 years of experience in the Pharmaceutical industry including an understanding of the drug development process
Significant eCOA and/or trial management experience with technical expertise in eCOA
Strong experience developing standards strategies and leading implementation
Experience in eCOA study design
Demonstrated experience of project, vendor management
Practical experience interfacing and achieving concordance with multiple stakeholders
Ability to think critically and understand complex eCOA Study Design
Strong written and verbal communication skills, leadership, decision-making, influencing and negotiating skills
Knowledge of clinical research, FDA, ICH, CGP, related regulatory requirements, CDISC
Benefits
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental and vision coverage
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