Clinical Data Coordinator II India Data Management

Quanticate International Limited; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Flexible working hours

Holidays including annual and sick leave

Medical insurance for self and family

Gratuity

Accidental coverage

Learning development opportunities

Job summary

A leading data-focused CRO in Bengaluru is seeking a Clinical Data Coordinator II to oversee Clinical Data Management activities across various studies. Responsibilities include managing data quality, reviewing CRFs, and ensuring compliance with ICH-GCP standards. The ideal candidate will have prior Clinical Data Management experience and familiarity with CDM systems. This role offers a competitive salary and various professional development opportunities in a supportive environment.

Qualifications

• Prior experience in Clinical Data Management or a similar role.
• Hands-on experience with at least one CDM system.
• Solid knowledge of ICH-GCP guidelines.
• Strong understanding of Clinical Data Management processes.
• Hands-on experience with at least one CDM system such as Oracle Clinical, Medidata Rave or Inform.

Responsibilities

• Support end-to-end Clinical Data Management activities across multiple studies.
• Review CRFs critically, identifying data inconsistencies.
• Manage self-evident queries within the database.
• Perform quality control checks on data entry.
• Raise, track, and resolve data queries and DCFs.
• Manage self-evident queries and data changes within the database.
• Perform quality control on data entry and outputs.
• Support study close-out activities and archival documentation.
• Ensure compliance with SOPs, ICH-GCP, regulatory requirements, and client standards.
• Contribute to process improvement 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 with reports.
• Take on ad-hoc tasks to support project and team objectives.

Skills

Attention to detail

Analytical thinking

Written communication

Verbal communication

Organization

Time management

Team collaboration

Tools

Microsoft Word

Microsoft Excel

Oracle Clinical

Medidata Rave

Inform

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 world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

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

Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.

• Competitive salary
• Flexible working hours
• Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
• Medical Insurance for self and immediate family
• Gratuity
• Accidental Coverage
• Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)