Role Summary
The Senior Associate, eCOA Manager, Clinical Data Collection Strategies supports the implementation and management of Electronic Clinical Outcome Assessment (eCOA) and related patient technologies across Pfizer Research & Development. As a member of the Patient Data Strategies (PDS) team, you will enable clinical study teams to use assigned patient data technologies, taking ownership of sub-projects within the initiative and coordinating with stakeholders to ensure efficient, high-quality, and low-regulatory-risk eCOA implementation. The role may involve technologies allied to eCOA, and requires the ability to work autonomously as well as collaboratively in a highly interactive team.
Responsibilities
- Assist in the implementation and management of eCOA and related patient technologies across Pfizer R&D.
- Own sub-projects within the overall initiative, engaging multiple stakeholders to enable study teams to implement eCOA effectively and with high quality and low regulatory risk.
- Consider technologies allied and parallel to eCOA as part of the role.
Qualifications
- Required: Bachelor’s degree or equivalent in a scientific discipline; 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; 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.
- Required: 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 in Statistics, Computer Science, or related field or equivalent experience.
- Preferred: Relevant pharmaceutical industry experience; experience using data visualization tools; proficiency 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 in a scientific discipline required
- Master’s degree in Statistics, Computer Science or related field preferred
Additional Requirements
- Physical/mental: Primarily office-based; substantial computer work and presentations.
- Travel: Ability to travel approximately 5–10%.
- Work Location: Hybrid