Senior Consultant - eCOA Services
$80,000–$200,000 year
HybridBoston, Massachusetts, United States
Job Summary
Review protocols and support design and configuration of eCOA solutions. Build, design, and consult on eCOA implementations while creating, reviewing, and managing deliverables including timelines, User Acceptance Testing, and design configurations. Facilitate and lead multi-study portfolios, drive operational improvements, and troubleshoot delivery issues. Provide technical advice to project managers, developers, validation, and customer support staff. Review and support Data Management activities and queries. Own all areas of eCOA implementation with a holistic understanding of the industry. This role requires 7+ years of eCOA industry experience and a four-year degree or equivalent. Includes ~5-10% travel.
Required Qualifications
- Four-year degree or equivalent experience
- 7+ years of eCOA industry experience
- Ability to take the initiative and work proactively
- Superior organizational and communication skills
- Proven ability to work independently in a dynamic, fast-paced environment but also as part of a team
- A logical approach to problem-solving and an excellent eye for detail
- Excellent verbal and written communication, interpersonal, and presentation skills
- Ability to travel (~5-10%)
Desired Qualifications
- Data management experience
- Working knowledge of clinical data applications (EDC, RTSM, eCOA)
- Clinical trial industry knowledge
- Working knowledge of FDA E6, E8, and 21 CFR Part 11
- Audit preparedness
- JSON programming
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