Job Posting: Clinical Systems Manager (eCOA Technical Specialist)

Location: Remote (Must reside in Texas, Georgia, Florida, North Carolina, South Carolina or Arizona)

About the Role

We are seeking a Clinical Systems Manager with expertise in electronic Clinical Outcome Assessment (eCOA) technologies. This role is pivotal in ensuring high-quality delivery of eCOA services for global clinical trials. The ideal candidate will have 2-3 years of hands-on experience with eCOA vendors and a strong background in managing eCOA specifications, governance, and project timelines.

Key Responsibilities

eCOA Service Area Management:

• Accountable for quality delivery and expertise in eCOA service operations.
• Oversee study-level system requirements meetings with eCOA vendors and stakeholders.

Documentation and Design:

• Assist in the design and development of study-specific technical documents.
• Partner with Data Management (DM) teams to define requirements for data transfers.
• Document processes in systems like Merit to ensure quality and consistency.

Project Oversight:

• Manage project timelines and associated activities, including vendor coordination.
• Handle issue resolution independently, escalating when necessary.
• Identify and track study-related technical issues to resolution.

Quality Assurance:

• Manage the creation and execution of user acceptance tests (UAT).
• Provide frameworks for continuous process and quality improvement.

Collaboration:

• Advise clinical trial managers on best practices for eCOA implementation.
• Ensure seamless communication and coordination across global teams.

Qualifications

• Bachelor’s Degree in life science, computer science, engineering, business, or a related discipline.
• 4+ years of experience in clinical development.
• Hands-on experience implementing clinical systems (e.g., CTMS, EDC, IVRS, ePRO).
• Knowledge of Good Clinical Practices (GCP) and FDA regulations.
• Strong project management skills, including PMP certification.
• Vendor management expertise with excellent time management and organizational abilities.
• Ability to work effectively in team environments with minimal supervision.
• Required: Proficiency in eCOA technical specifications, including writing, modifying, and providing feedback on eCOA specifications.
• Required: Experience managing eCOA projects, resolving issues, and maintaining governance processes.
• Required: Proven ability to work collaboratively and communicate effectively in remote, team-based settings.

Why Join Us?

This role offers the opportunity to make a meaningful impact in clinical research by ensuring the seamless integration of eCOA technologies in global trials. Join a team of innovative professionals committed to excellence in clinical systems management.