We are Growing! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization.

Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

• 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

• 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.