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 position works as a member of the Patient Data Strategies (PDS) team to help clinical study teams use assigned patient data technologies. The role will own sub-projects within the overall initiative, engaging a variety of stakeholders to ensure study teams enable eCOA implementation that is efficient, high quality, and with the lowest regulatory risk. Familiarity with technologies allied and parallel to eCOA is also required. The role requires autonomous work on assigned items as well as strong collaboration within a team, with potential candidates bringing experience 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 Pfizer Research & Development; own sub-projects within the initiative; engage stakeholders to enable efficient, high-quality, and low-regulatory-risk eCOA implementations.
- Collaborate with the Clinical Data and Information Sciences (CDIS) and Clinical Development & Operations (CD&O) organizations and the Patient Data Strategies (PDS) team to support study teams in using assigned technologies.
- Consider technologies allied to eCOA and contribute to process management and change management efforts to improve adoption and outcomes.
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; 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 project and vendor management; ability to interface with multiple stakeholders; 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.
Education
- Bachelor’s degree in a scientific field required; Master’s degree preferred.
Additional Requirements
- Travel: ability to travel approximately 5–10%.
- Work Location: Hybrid.