Join Biorasi - Elevate Your Career in Clinical Research

Are you ready to take your career to the next level? At Biorasi, we are continually evolving and growing, and we want to support your career journey. Our award-winning, customer-focused, full-service clinical research organization is built on innovation, collaboration, dynamism, and a balanced work-life ethos. We value your strengths and aim to help you thrive in your career.

About Biorasi

Biorasi is at the forefront of clinical research, looking for passionate top performers who share our enthusiasm for advancing new therapies. Whether you're a seasoned clinical trial veteran or a newcomer eager to make an impact, Biorasi offers you the chance to be an integral part of a growing, global company in the expanding clinical research industry.

Role Overview: Associate II, Data Management

We are seeking a motivated Associate II, Data Management to join our team. In this role, you will:

• Perform data cleaning procedures and maintain 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.
• Assist in database (EDC) design, setup, and administration under supervision.
• Create database validation specifications, CRF Completion Guidelines, and User Acceptance Testing scripts for study databases.
• Conduct User Acceptance Testing for development study databases.
• Prepare, collect, and archive study-related clinical documents and manage TMF activities.
• Assist with database lock and the completion of final study reports.
• Support departmental audit and compliance requirements as needed.
• Develop data management reports and programs for clinical trial data management.
• Respond to EDC help desk requests.
• Assist with Project Management requests and other data management duties as assigned.

Your Profile

Successful candidates will possess:

• A Bachelor’s degree or equivalent, preferably in a scientific or IT-related discipline. An advanced degree or diploma is preferred.
• Fluency in English (oral and written).
• 2 to 4 years of prior data management experience.
• Knowledge of FDA, ICH, and GCP guidelines.
• Proficiency in MS Office and computer literacy.
• Excellent organizational skills.
• Strong verbal and written communication skills.
• Exceptional attention to detail.

Ready to make a difference in clinical research? Apply now for a quicker response through the link below:

Company Name: Lifelancer

Job Title: Associate II, Data Management