Senior Associate, Data Management - Hybrid, Mumbai

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)
• 2 to 4 years prior data management experience.
• 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.

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at [email protected].

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.