Job Overview:
May support LDM with the review, maintenance and update of External Vendor data received from central vendor or local laboratories. Working to ensure departmental SOPs, guidelines and global standards are followed to maintain data integrity and ensure consistency across all projects.
Summary of Responsibilities:
• Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly.
• May support LDM in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
• Review data discrepancies generated by study-specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
• May support LDM to perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.
• Assist with review of External Data edit checks, External Data status reports and External Data listings.
• Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges and maintain proper documentation.
• Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database.
• May support LDM to communicate to vendors and client problems involving data transfers, data point issues and validation issues with initial oversite for support of this communication from EDS 2 or above.
• 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.
• Fluent in English, both written and verbal.
Experience (Minimum Required):
• 3 years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• Basic understanding of medical terminology a plus.
• Strong organizational, planning, and critical-thinking skills.
• Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective interactions with sponsors and internal colleagues.
• Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
• Ability to use standard Microsoft suite of software products.
• Strong technical aptitude.
• Ability to maintain confidentiality of data and information during interaction with staff at all levels.
• Understanding of ICH-GCP principles.
Physical Demands/Work Environment:
• Perform in a general or remote office setting.
• Sit for sustained periods of time in front of monitor.
• Perform with multiple interruptions.
• Requires frequent priority adjustment.
• Requires the ability to manage multiple priorities.
• Should be willing to work in flexible shifts as per business requirement.
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