Quanticate
Biotech
ClinicalDataCoordinatorII
Neural analysis suggests this role is
optimal for Mid candidates.
“Clinical Data Coordinator II at Quanticate. Skills: Clinical Data Management, Data quality, Regulatory compliance. Support Clinical Data Management activities. Assist with database testing”
Industry & Context.
Analytical thinking
What They're Looking For.
Must Have
Understanding of Clinical Data Management processes, Knowledge of ICH-GCP guidelines, Familiarity with CRO and sponsor-driven study standards, Prior experience in Clinical Data Management, Hands-on experience with at least one CDM system, Proficient in Microsoft Word, Proficient in Microsoft Excel
Nice to Have
Experience supporting multiple studies, Managing competing priorities
What You'll Do.
Support Clinical Data Management activities
Assist with database testing
Assist with database validation
Prepare study-specific documentation
Maintain study-specific documentation
Review CRFs critically
Identify data inconsistencies
Identify missing information
Raise Data Clarification Forms
Track Data Clarification Forms
Resolve Data Clarification Forms
Manage self-evident queries
Manage allowable data changes
Perform quality control checks
Support study close-out activities
Prepare archival documentation
Ensure compliance with SOPs
Ensure compliance with ICH-GCP
Ensure compliance with regulatory requirements
Ensure compliance with client standards
Contribute to process improvement
Contribute to data management best practices
Perform medical coding
Collaborate with offshore teams
Collaborate with programming teams
Provide project updates
Support progress tracking
How You'll Work.
Team & Collaboration
Offshore data processing teams; Programming teams
Communication Scope
Written communication; Verbal communication
Process & Methodology
Progress tracking
Full Job Description
At Quanticate, we're pioneers in providing top-tier statistical and data management support to our clients. Are you passionate about clinical research and data excellence? Do you thrive in fast-paced, dynamic environments where your attention to detail can make a real impact on patient outcomes? We’re looking for a Clinical Data Coordinator II to be at the heart of our studies, ensuring top-quality data from start to finish. ### **What You’ll Do** * Support end-to-end Clinical Data Management activities across multiple studies * Assist with database testing and validation prior to study activation * Prepare and maintain study-specific Data Management documentation * Review CRFs critically, identifying data inconsistencies, errors, or missing information * Raise, track, and resolve data queries and Data Clarification Forms (DCFs) * Manage self-evident queries and allowable data changes within the database * Perform quality control checks on data entry and database outputs * Support study close-out activities, including preparation of archival documentation * Ensure compliance with SOPs, ICH-GCP, regulatory requirements, and client standards * Contribute to process improvement initiatives and data management best practices * Perform medical coding activities when assigned * Collaborate with offshore data processing and programming teams * Provide project updates and support progress tracking using reports and metrics * Take on ad-hoc tasks as required to support project and team objectives ### **What You’ll Gain** * Exposure to full lifecycle Clinical Data Management across diverse studies * Hands-on experience working with industry-leading CDM systems * Opportunity to collaborate with cross-functional and global teams * Development of leadership, coordination, and project oversight skills * A supportive environment that values quality, compliance, and continuous improvement * Career growth within a regulated and evolving clinical research setting _Quanticate is the w
Applying for this Clinical Data Coordinator II role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
ANONYMOUS · UNFILTERED
What do employees actually say about Quanticate?
Real rants from real employees. Read before you apply.