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Sr Associate eCOA Manager

Pfizer
Remote friendly (Pennsylvania, United States)
United States
$80,300 - $133,900 USD yearly
Clinical Research and Development

Role Summary

Use Your Power for Purpose. Our mission is straightforward: support healthcare decisions that ensure the safe and effective use of medications. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.

Responsibilities

  • As part of the Clinical Data and Information Sciences (CDIS) group within the Clinical Development & Operations (CD&O) organization, assist in the implementation and management of Electronic Clinical Outcome Assessment (eCOA) and other related Patient technologies throughout Pfizer Research & Development.
  • Work as a member of the Patient Data Strategies (PDS) team to help clinical study teams use assigned patient data technologies.
  • Take ownership of sub-projects within the overall initiative, engaging a variety of stakeholders and customer groups to enable study teams to implement eCOA in clinical studies efficiently, consistently, and with high quality and low regulatory risk.
  • Consider technologies allied and parallel to eCOA as required; work autonomously on assigned items and as part of a collaborative team.
  • Familiarity areas may include Mobile Technologies, Mobile App usage and Deployment, PRO technologies, eConsent, Medical Devices, Vendor relationship Management, Process Management, and Change Management.

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 experience in project and vendor management.
  • Practical experience interfacing with multiple stakeholders to achieve concordance.
  • Ability to think critically and understand complex eCOA study designs.
  • Strong written and verbal communication skills, leadership, decision-making, influencing, and negotiating abilities.
  • Knowledge of clinical research, FDA, ICH, CGP, regulatory requirements, and CDISC.
  • Preferred: Master’s degree; 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.

Education

  • Bachelor’s degree in a scientific discipline (required)
  • Master’s degree in Statistics, Computer Science, or related field (preferred)

Additional Requirements

  • Travel: Ability to travel approximately 5–10%.
  • Work Location: Hybrid.
  • Physical/Mental Requirements: Primarily office-based work involving computer use and presentations.