Empowering Muscle Empowering Lives
Contract Clinical Systems Manager
Location
United States
Posted
5 days ago
Salary
$110 - $120 / hour
Job Description
Job Requirements
- BS degree in information technology, computer science, computer engineering, statistics, or bioinformatics
- 7+ years of experience supporting GxP computerized systems in clinical research environments (sponsor, CRO, or biotech)
- Strong expertise in GxP validation principles (CSV lifecycle and risk-based validation)
- Hands-on experience with major clinical platforms (e.g., Veeva eTMF, Medidata Rave EDC & CTMS, IRT/RTSM, RBQM/RACT, CDR)
- Demonstrated experience leading system evaluations, validation deliverables, and UAT oversight
- Working knowledge of global regulatory expectations (FDA, EMA, MHRA)
- Understanding of clinical trial data and regulations (CDISC, Good Clinical Practice, 21 CFR Part 11)
- Experience in developing business specifications/requirements and user acceptance testing for computer systems
- Familiarity with database concepts, data validation, and data model process from internal and external sources
- Knowledge of AI technology preferred
- Must possess good interpersonal skills
- Excellent written and verbal skills required
- Must display strong analytical and problem-solving skills
- Attention to detail required
- Good organizational skills, ability to manage multiple tasks
Benefits
- Our employees come from different backgrounds, and we celebrate those differences.
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