Assistant Clinical Data Analyst
Fortrea
Bengaluru, Karnataka, IndiaFresher2h agovia LinkedIn
About the Role
This role supports data management operations within clinical research, ensuring compliance with regulatory requirements and Good Clinical Practices.
Key Responsibilities
- Follow departmental Standard Operating Procedures and Work Instructions.
- Complete required trainings according to timelines.
- Review and action queries on an ongoing basis, updating the database appropriately upon meeting quality expectations.
- Work according to assigned Data Management related operational data flows.
- Review reports and take actions as defined in the Data Management Plan (DMP) or eCRF review manual.
- Perform ongoing and final consistency checks, and data listings review as defined in the DMP and eCRF Review Manual.
- Ensure all Data Management activities are conducted in compliance with relevant regulatory requirements and Good Clinical Practices.
- Setup and maintenance of EDC User Access Accounts for databases.
- Ensure EDC user requests for database access are completed accurately and efficiently.
- Troubleshoot and correct User access issues; follow up with EDC vendor for technical support as needed.
- Create, format, and distribute User Access Report to Project Managers/Lead Data Manager for reconciliation of User access.
- Assist with decommissioning/archiving tasks, generating reports and distributing reports.
- Perform other ad hoc tasks as assigned.
Requirements & Tech Stack
- Ability to use computer and departmental tools.
- Experience in clinical research.
- Demonstrated ability to organize and communicate effectively.
- Demonstrated ability to pay attention to detail.
- Ability to work well with others.
- Ability to deliver consistent high quality of work.
- Experience with EDC systems (implied by responsibilities).
Qualifications
- University / college degree in life sciences, health sciences, information technology, or related subjects, or a certification in allied health professions from an appropriate accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Work environment may be office-based or home-based.
May require overtime and weekend work.
Willingness to work in flexible shifts as per business requirement.