Overview
Clinical Data Analyst II role managing end-to-end resolution of data discrepancies between clients (Sponsors, CROs, and Investigators) and Labcorp databases.
What you'll do
- Collaborate with clients and CRO Data Managers to develop and execute study-specific query management and data cleaning strategies.
- Manage reconciliation activities, monitor data lock schedules, and ensure completion of deliverables within study timelines.
- Perform critical data revisions as needed to achieve study milestones, adhering to established data revision and data cleaning processes.
- Analyze, investigate, and resolve data discrepancies in compliance with GCP, regulatory requirements, and project standards.
- Serve as the primary liaison between clients, Labcorp departments, and cross-functional teams for data reconciliation and data quality activities.
- Lead cross-functional communications and stakeholder engagement to drive timely resolution of data issues, escalations, and project risks.
- Respond to client inquiries, negotiate priorities and timelines, and provide effective solutions to support study objectives.
- Review study documentation, including protocols and Statements of Work (SOWs), to ensure compliance with study and contractual requirements.
- Perform quality reviews of data updates, query resolutions, reports, and communications to ensure accuracy, consistency, and compliance.
- Generate, analyze, and interpret reconciliation and database reports to identify issues, trends, and improvement opportunities.
- Proactively identify, escalate, and manage risks that may impact data quality, reconciliation activities, or study milestones.
- Effectively manage workload and competing priorities to meet project deadlines, turnaround times, and client expectations.
- Support the implementation, standardization, and continuous improvement of global processes, procedures, and best practices.
- Assist with audits, CAPA activities, reportable issues, inspections, and other quality and compliance initiatives.
- Provide advanced technical and administrative support for CLS data processing systems, lead resolution of complex process and application issues, and coach team members to promote knowledge sharing and operational excellence.
What you'll need
- Bachelor's degree in science or related field.
- Minimum of 5 years of professional experience.
- Strong understanding of data revision/reconciliation processes and lab/clinical data management.
- Proficient in English, both written and verbal.
Nice to have
- Bachelor's or master's degree in science, Life Sciences, Data Management, or related field.
- Minimum of 6 years of relevant experience.
- Prior experience in lab/clinical data management or healthcare, medical or laboratory functions.
- Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
Details
- Location: Yeshwantpur, Bengaluru, Karnataka, India.
- Work schedule: Rotational shift, PM 02:00 PM – 11:00 PM or Night 06:00 PM – 03:00 AM.
Read the full description and apply on the company’s own careers page.