ECOA Technical Project Manager

trial knowledge, and project leadership to support high‑quality, compliant digital data collection initiatives.
Description of Role & Responsibilities
• Execute COA systems development process from kickoff to system go live, ongoing system change control, system closeout, and database lock activities.
• Define/redesign COA development processes across vendor base. Identify areas for process improvement and lead improvement activities.
• Create and enforce the use of COA systems standards. Responsibilities may include creation/revision of COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.
• Perform peer‑review of the COA systems specific documentation for quality (e.g., comparing paper COA measures with developer version).
• Manage vendor performance and relationships. Responsibilities may include defining and implementing processes with vendor representatives, monitoring and analyzing vendor and client performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
• Serve as project manager of all COA systems activities for assigned protocols.
• Use interpersonal, negotiating, and project‑management skills to perform the following tasks:
• Project plan development, execution, and change control. Coordinate resolution & risk mitigation of all IRT & COA systems related issues and end‑of‑study vendor deliverables.
• Activity definition and sequencing, duration estimation, schedule development, and schedule control.
• Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control).
• Communication planning, information distribution, performance reporting, and project closure.
• Obtain internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.
• Provide support for successful integration of client and vendor systems.
• Provide support for problem resolution between COA vendors and client’s Clinical Trial Team.
• May participate in training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross‑functional internal and external communication as needed.
• May provide support for the development/maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation.
• May mentor new staff.
• May lead a continuous improvement special project or any other project or perform any other COA related task deemed appropriate by management.
Minimum FTE Years of Experience
• Minimum of 3 years’ experience in eCOA Project Management.
• Able to read and interpret clinical trial protocols.
• Effective verbal and written communication skills.
• Attention to detail.
• Stakeholder engagement and collaboration experience.
• Cross‑functional collaboration.
• Ability to adapt in a fast‑paced environment.
• Risk management experience.
• Familiarity working with Microsoft Project.
• 2 days a week in the client office required.
Educational Requirements
• B.A. or B.S. degree in Computer Science, Biology, or a related discipline.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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