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.
