Clinical Systems SpecialistApply Now
Location: Somerville, Massachusetts
Employment Type: Contract
Contract length: 12+ Months
- Bachelors Science Degree in Computer Science, Bioinformatics, Business Information systems or in a relevant technical field or equivalent technical experience
- 5+ years of Clinical Information System management experience
- Experience with EDC, IRT and eTMF systems
- Prior experience working with multiple Clinical Information Systems simultaneously
- Knowledge of relational databases and experience with JReview® reporting software is strongly preferred
- Detailed knowledge of ICH and FDA GCP guidelines.
- Detailed knowledge of FDA CFR Part 11 regulations and general knowledge of FDA and other global clinical trial regulations
- Experience managing Clinical Information System vendors
- Excellent communication skills
- Perform activities related User and Site Account Administration and Maintenance within all clinical systems across the clinical platforms for internal and external stakeholders
- Perform Clinical System Account Creation/management, Issue resolution, process improvement, enhancements, validation and migration improvement
- Lead/perform clinical information system administration including the definition of best practices and SOPs; creation of SOPs, best practices, training, global work streams related to user account requests, administration and management
- Development and utilization of reports across the clinical systems, identification of efficiencies in ongoing review, trend identification and development of best practices and data flow solutions
- Collaborates with clinical development and informatics contributors.
As the vendor manager for the Contract Recruiting team, Chintan is responsible for contract negotiation, continuing to expand relationships with IT service providers, and functional reporting including metrics for billability, operational issues, and investigated root causes.
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