About the role
Your role:
- Perform data cleaning procedures, maintenance review of EDC queries, including query issuance and resolution
- Develop data management listings, data management plans, data validation plans and system validation plans.
- Maintain user access to study systems, ensuring compliance with 21 CFR 11.
- Participate in vendor data reconciliation.
- Perform, under supervision, database (EDC) design, setup and administration.
- Develop database validation specifications, CRF Completion Guidelines, User Acceptance Testing scripts of data for study databases.
- Perform User Acceptance Testing for development study databases.
- Prepare, collect, and archive study related clinical documents and TMF activities.
- Assist with database lock and the completion of final study reports.
- Assist with departmental audit and compliance requirements as needed.
- Develop data management reports.
- Develop and review programs and databases for management of data from clinical trials.
- Respond to EDC help desk requests.
- Assist with Project Management requests as requested.
- Other data management duties and responsibilities as assigned
Your Profile:
- Bachelor’s degree or equivalent, preferably in a scientific or IT related discipline. Advanced degree or diploma preferred.
- Fluent English (oral and written)
- 1 to 3 years prior data management or successful completion of at least 1 year as Associate 1, Data Management (or equivalent).
- Knowledge of FDA, ICH, and GCP guidelines.
- Computer literacy, proficiency in MS Office.
- Excellent organizational skills.
- Strong verbal and written communications skills.
- Ability to exercise excellent attention to detail.
We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.