IT Analyst, Electronic Submissions - United States
Charles River (company)
Perform systems analysis and requirements gathering for large and small scale system implementations within regulated and/or non-regulated IT environments. Create electronic data specifications for sponsors.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Validate software for electronic submissions, which includes requirements gathering, test script writing, test script execution and other validation tasks.
- Perform review and appraisals of computer hardware, software and associated products for electronic submissions.
- Ensure work is compliant with applicable guidelines and regulations (e.g., SOP, GLP, PLC, MVP, etc.).
- Provide software training and support as required to end users and computer department staff.
- Assist users, with to identifying and resolving software issues.
- Provide support to users for data capture for electronic submission compliance.
- Manage standardized glossaries in Centrus and co-ordinate with all other collection system glossaries administrators.
- Understand industry documents such as the study plan/protocol, study schedules, deviations, drafts and final reports in order to compare them with the electronic data and ensure the data is accurate.
- Create SEND datasets for electronic submissions and piloting purposes.
- Assist with global system control change for electronic submissions compliance.
- Create and maintain user’s templates and implement Provantis Import module for non-Provantis/manual data.
- Ensure issues are identified, tracked, reported on and resolved in a timely manner.
- Consistently deliver high-quality services to customers and manage customer expectations effectively.
- Communicate effectively with customers to identify needs and evaluate alternative business solutions with project management.
- Lead internal teams/task forces as needed.
- Perform all other related duties as assigned.
- Education: Bachelor’s degree (B.A. /B.S.) or equivalent in Computer Science or related discipline.
- Experience: One to two years related experience.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None
- Other: Knowledge of current IT technologies. Possess an overall understanding of safety assessment data as well as a general understanding of CDISC Standards. Knowledge of MS Excel required. Requires excellent communication and interpersonal skills. Requires great attention to detail. Ability to work well in a team environment.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet