Quanticate

Biotech

ClinicalDataCoordinatorII

₹12–19L ~AI est. Bengaluru, Karnataka, India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“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.

Biotech
Problems you'll solve

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

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