Summary of Responsibilities:

• Follow applicable departmental Standard Operating Procedures and Work Instructions.
• Complete required trainings according to timelines.
• Within the specified timelines review and action queries on an ongoing basis and upon meeting the quality expectations update database appropriately, as assigned.
• Work as per assigned Data Management related operational data flows.
• Review reports and take actions as defined in the DMP or eCRF review manual, as assigned.
• Perform ongoing and final consistency checks, data listings review as defined in the DMP and eCRF Review Manual, as assigned.
• Ensure that 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 and other ad hoc tasks.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University / college degree (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.

Experience (Minimum Required):

• 0 - 1 year 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. · Ability to use computer and departmental tools.

Physical Demands/Work Environment:

• Office and/or homebased work environment.
• May require overtime and weekend work as required.
• Should be willing to work in flexible shifts as per business requirement.

Learn more about our EEO & Accommodations request here.