Senior Specialist, Clinical Data Management, Hybrid
$117,000–$184,200 year
Hybrid · Rahway, New Jersey, United States or West Point, Pennsylvania, United States
Job Summary
Senior COA Systems Specialist leads end-to-end COA systems development and standardization, manages vendor performance, and supports training and education for stakeholders. Responsibilities include coordinating from project kickoff to system go-live, enforcing COA standards, performing peer reviews of COA documentation, monitoring vendor performance, and acting as the project manager for COA activities across protocols. The role involves defining processes, driving continuous improvement, risk management, stakeholder communications, and cross-functional collaboration with internal teams and external vendors. Must contribute to training materials and documentation, and may mentor staff. Hybrid work arrangement and a strong emphasis on regulatory compliance and process improvement are expected.
Required Qualifications
- B.A. or B.S. in life sciences, computer science, engineering, or related discipline
- 6 years of experience in Clinical Data Management with at least 4 years in COA-related work
- Knowledge of COA systems development processes and clinical development
- Strong written and verbal communication skills
- Ability to manage multiple tasks, meet deadlines in a complex environment
- Experience with Change Management, UAT, Project Management, Risk and Issue Management, Regulatory Compliance
Additional Requirements
- US residents only per policy
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