Role Summary
Sr Associate eCOA Manager — The role supports the implementation and management of Electronic Clinical Outcome Assessment (eCOA) and related patient technologies within Pfizer Research & Development. The position is part of the Patient Data Strategies (PDS) team, enabling study teams to implement eCOA in clinical studies efficiently, with high quality and low regulatory risk. The candidate will work autonomously on assigned items and collaborate with a cross-functional team, with a focus on technologies allied to eCOA.
Responsibilities
- Assist in the implementation and management of Electronic Clinical Outcome Assessment (eCOA) and related patient technologies across Pfizer R&D, helping clinical study teams use assigned patient data technologies.
- Own sub-projects within the overall initiative, engaging diverse stakeholders to enable study teams to implement eCOA efficiently, consistently, and with regulatory compliance.
- Consider technologies allied and parallel to eCOA, and contribute to process and change management as needed.
- Work autonomously on assigned work items and as a member of a collaborative, interactive team.
Qualifications
- Required: Bachelor’s degree or equivalent in a scientific discipline; minimum 3–5 years of experience in the pharmaceutical industry with understanding of the drug development process.
- Required: Significant eCOA and/or trial management experience with technical expertise in eCOA.
- Required: Strong experience developing standards strategies and leading implementation.
- Required: Experience in eCOA study design.
- Required: Demonstrated experience in project and vendor management; practical experience interfacing with multiple stakeholders; ability to think critically about complex eCOA study design; strong written and verbal communication, leadership, decision-making, influencing and negotiating skills; knowledge of clinical research, FDA, ICH, CGP, regulatory requirements, and CDISC.
- Preferred: Master’s degree; relevant pharmaceutical industry experience; experience using data visualization tools; experience with commercial clinical data management systems and/or EDC products; strong analytical and problem-solving skills; ability to work collaboratively in a team; excellent organizational and time management skills.
Skills
- Mobile Technologies
- Mobile App usage and deployment
- PRO technologies
- eConsent
- Medical devices
- Vendor relationship management
- Process management
- Change management
Education
- Bachelor’s degree or equivalent in a scientific discipline required
- Master’s degree in Statistics, Computer Science, or related field preferred
Additional Requirements
- Physical/Mental: Primarily office-based, desk work and presentations.
- Travel: Ability to travel approximately 5–10%.