Senior Consultant - eCOA Services
New
V
Veeva SystemsClinical-trial consulting
Source API remote eligibility restrictions: United StatesFull-TimeSenior
SalaryBase pay: $80,000 - $200,000
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Job Details
- Experience
- 7+ years of eCOA industry experience
- Required Skills
- Project ManagementData management
Requirements
- Four-year degree or equivalent experience.
- 7+ years of eCOA industry experience.
- Ability to take initiative and work proactively.
- Strong organizational and communication skills.
- Ability to work independently in a dynamic, fast-paced environment and as part of a team.
- Logical problem-solving approach and attention to detail.
- Verbal and written communication, interpersonal, and presentation skills.
- Ability to travel approximately 5–10%.
- Data management experience is a nice-to-have.
- Working knowledge of clinical data applications (EDC, RTSM, eCOA) is a nice-to-have.
- Clinical trial industry knowledge and working knowledge of FDA E6, E8, and 21 CFR Part 11 are nice-to-haves.
- Audit preparedness and JSON programming are nice-to-haves.
Responsibilities
- Review protocols and support eCOA design and configuration.
- Build, design, and consult on eCOA solutions.
- Create, review, coordinate, and manage timelines, KOM, URS, User Acceptance Testing, and eCOA design and configuration deliverables.
- Review and support data management activities and queries.
- Lead and manage multi-study portfolios and drive operational improvements.
- Facilitate and troubleshoot issues associated with eCOA system delivery.
- Provide technical advice and assistance to project managers, developers, validation staff, and customer support staff.
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