What are the responsibilities and job description for the eCOA Technical Specialist position at CornerStone Technology Talent Services?
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 : 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.
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