Clinical Data Associate I
About the Role
Role & Responsibilities
• Lead advanced data review, cleaning, and discrepancy management to ensure data integrity, timeliness, and inspection readiness across assigned studies
• Identify, resolve, and update data discrepancies and perform required updates in the data management database
• Generate, track, and resolve data clarifications and queries, ensuring appropriate documentation and closure within timelines
• Review data listings for accuracy, completeness, and consistency, and resolve issues based on protocol and data standards
• Analyze and resolve data validation outputs and other data management reports, following the Data Validation Manual
• Perform Serious Adverse Event (SAE) and third-party vendor reconciliations and ensure issues are tracked to resolution
• Support CRF implementation and database updates where required, including applying CRF design in identified graphic design tools
• Produce regular project-specific status reports for CDM management and clients, highlighting risks, issues, and progress
• Partner with cross-functional teams to proactively identify risks, resolve issues, and deliver high-quality, analysis-ready datasets
• Maintain confidentiality and ensure adherence to regulatory guidelines, global SOPs/WPDs, and client expectations
Qualification
• Bachelor’s degree or equivalent in a relevant discipline
Experience
• 1.6 to 3 years of relevant Clinical Data Management experience
• Hands-on experience with RAVE / Veeva EDC required
Skills
• Clinical data review, query management, and discrepancy resolution
• SAE reconciliation and third-party vendor reconciliation experience
• Data listings review and data validation report analysis
• Understanding of protocol requirements and Data Validation Manual
• Knowledge of medical and clinical trial terminology
• Strong attention to detail, numerical accuracy, and analytical/problem-solving skills
• Strong written and verbal communication with good English grammar
• Customer focus, stakeholder management, and teamwork with flexibility to work independently
• High confidentiality and sound judgment in handling clinical and proprietary data
• Computer proficiency and ability to use interactive clinical data systems and MS Office
About The Company
Thermo Fisher Scientific, through its PPD clinical research services portfolio, supports global clinical trials and data management delivery for leading pharmaceutical and biotech clients. With a mission to make the world healthier, cleaner, and safer, Thermo Fisher enables clinical research through scientific expertise, scalable FSP models, and technology-driven services across international studies.
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