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.
Skills Required
- University or college degree in life sciences, health sciences, information technology, or a related field, or an accredited allied health certification
- Relevant equivalent experience may substitute for educational requirements
- 0–1 year of experience in clinical research
- Ability to organize and communicate effectively
- Strong attention to detail
- Ability to work well with others
- Ability to deliver consistent, high-quality work
- Ability to use computers and departmental tools
- Willingness to work flexible shifts, overtime, or weekends as required
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What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
