Biorasi is a leading CRO known for its innovative, customer-centric approach in clinical trials. The company promotes a collaborative and balanced work environment. With its focus on employee growth, Biorasi offers career development, training, and extensive benefits, ensuring a great professional journey for every team member. From clinical trial veterans to industry newcomers, Biorasi welcomes anyone eager to contribute to global healthcare.
Responsibilities of the Associate, Data Management Role
As an Associate in Data Management, you will work closely with the clinical data sciences team. Key responsibilities include:
- Data Cleaning & EDC Query Handling: Perform data cleaning tasks and manage queries in Electronic Data Capture (EDC) systems, including issuing and resolving queries under supervision.
- Data Management Plan Development: Assist in developing data management tables, validation plans, and data management plans.
- User Access Management: Manage user access to study systems while ensuring compliance with 21 CFR 11 regulations.
- Responding to Help Desk Requests: Support help desk requests from study sites and sponsors.
- Database Validation & Testing: Assist in database validation, user acceptance testing (UAT), and generating completion guidelines for case report forms (CRF).
- Participation in Meetings: Attend internal team meetings and sponsor meetings, and document minutes for all relevant stakeholders.
- Report Preparation & Document Management: Collaborate in generating data reports and managing clinical study documentation.
- Vendor Data Management: Participate in managing vendor data and other project management activities.
Qualifications for the Data Management Role
To be successful in this role, candidates must meet the following qualifications:
- Educational Background:
- Bachelor’s degree or equivalent, ideally in a scientific or IT-related discipline.
- Advanced degree or diploma in CDM will be considered an advantage.
- Experience:
- 0-1 years of experience in data management, clinical trials, or database administration is preferred.
Essential Skills for Success
Biorasi is looking for candidates with the following skills and attributes:
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- Proficiency in English: Fluency in both oral and written communication.
- Computer Literacy: Strong working knowledge of MS Office tools.
- Excellent Organizational Skills: Ability to handle multiple tasks with attention to detail.
- Communication Skills: Clear verbal and written communication.
- Detail-Oriented: Ability to spot inconsistencies and ensure data accuracy.
