Job Description

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.