Role & responsibilities

What Youll 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 Youll Gain

- Exposure to full lifecycle Clinical Data Management across diverse studies

- Hands-on experience working with industry-leading CDM systems

- Prospect 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

Preferred candidate profile

Knowledge:

- Strong understanding of Clinical Data Management processes

- Solid knowledge of ICH-GCP guidelines and regulatory requirements related to data handling

- Familiarity with CRO and sponsor-driven study standards

Work Experience:

- Prior experience in Clinical Data Management or a similar role

- Hands-on experience with at least one CDM system (e.g., Oracle Clinical, Medidata Rave, Inform)

- Experience supporting multiple studies or managing competing priorities is preferred

Skills:

- Excellent attention to detail and strong analytical thinking

- Good written and verbal communication skills

- Strong organizational and time-management abilities

- Ability to work effectively in a fast-changing, deadline-driven environment

- Comfortable working with offshore or remote teams

- Proficient in Microsoft Word and Excel

- Team-oriented mindset with the ability to motivate and collaborate effectively

📌 Clinical Data Coordinator 2 (Bengaluru)
🏢 Quanticate
📍 Bengaluru