Sr Associate eCOA Manager

Role Summary

Senior Associate, eCOA Manager, Clinical Data Collection Strategies is responsible for assisting in the implementation and management of Electronic Clinical Outcome Assessment (eCOA) and other related patient technologies throughout Pfizer Research & Development. The role works 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, engaging stakeholders to enable study teams to implement eCOA in clinical studies efficiently, consistently and with high quality and low regulatory risk. The role may involve technologies allied to eCOA. The candidate should be able to work autonomously as well as in a collaborative team, with potential familiarity in Mobile Technologies, Mobile App usage and Deployment, PRO technologies, eConsent, Medical Devices, Vendor relationship Management, Process Management, and Change Management.

Responsibilities

• Assist in the implementation and management of electronic clinical outcome assessment (eCOA) and related patient technologies across clinical studies.
• Own sub-projects within the overall initiative and engage diverse stakeholders to enable efficient, high-quality study execution with minimal regulatory risk.
• Collaborate with Clinical Data and Information Sciences (CDIS) and Clinical Operations (CD&O) to support technology-enabled data collection strategies.

Qualifications

• Required: Bachelor’s degree or equivalent in a scientific discipline; minimum 3–5 years of pharmaceutical industry experience with understanding of the drug development process.
• Required: Significant eCOA and/or trial management experience with technical expertise in eCOA; strong experience developing standards strategies and leading implementation.
• Required: Experience in eCOA study design; demonstrated project and vendor management; practical experience interfacing with multiple stakeholders.
• Required: Ability to think critically about complex eCOA study design; strong written and verbal communication, leadership, decision-making, influencing, and negotiating skills.
• Required: Knowledge of clinical research, FDA, ICH, CGP, related regulatory requirements, and CDISC.

Skills

• Mobile technologies, mobile app usage and deployment
• PRO technologies, eConsent, medical devices
• Vendor relationship management, process management, change management
• Data interpretation and communication of complex study designs
• Collaboration and teamwork in cross-functional environments

Education

• Bachelor’s degree or equivalent in a scientific discipline; Master’s degree in Statistics, Computer Science or related field preferred.

Additional Requirements

• Physical/mental: Primarily office-based, large periods at a computer with presentations.
• Travel: Ability to travel approximately 5–10%.