Clinical Data Management Associate II

eResearch Technology

India

Hybrid

INR 700,000 - 1,300,000

Full time

8 days ago

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Benefits offered by this job

Competitive pay and incentives
Provident fund and medical insurance
Engaging employee programs and local벤트
Modern office spaces and remote work柔
Opportunities for professional growth

Job summary

Clario, part of Thermo Fisher Scientific, seeks a Clinical Data Management Associate II to review, validate, and manage imaging study data, ensuring quality and regulatory compliance across therapeutic areas.

You will collaborate with project teams and sponsors, support data management plans, and contribute to data quality and study execution in a global environment.

Qualifications

  • Strong analytical and problem-solving skills.
  • Excellent attention to detail and data quality.
  • Excellent verbal and written communication in English.
  • Ability to work independently while collaborating with cross-functional teams.

Responsibilities

  • Review study documentation and project requirements to assess impacts on Clinical Data Management processes, standards, and deliverables.
  • Collaborate with cross-functional teams to support study setup, data collection strategies, and evolving project requirements.
  • Support the implementation and execution of data management plans for assigned imaging studies.
  • Define, execute, review, and maintain edit checks to identify discrepancies and ensure high-quality clinical data.
  • Review clinical and imaging-related data to identify inconsistencies, trends, and data quality issues.
  • Develop and maintain study data specifications, including data transfer specifications, system configuration specifications, and data validation requirements.
  • Create, review, and maintain transmittal forms and study documentation while ensuring compliance with established standards.
  • Collaborate with project teams to investigate and resolve data discrepancies and outstanding issues.
  • Track data-related issues through resolution and ensure timely follow-up with relevant stakeholders.
  • Prepare, validate, and deliver ad hoc data listings and study reports as required.
  • Identify system enhancements, bugs, or process improvement opportunities and coordinate communication with appropriate Product Management teams.
  • Maintain complete, accurate, and audit-ready study documentation throughout the study lifecycle.
  • Communicate project status, risks, and data quality concerns to supervisors and project stakeholders.
  • Contribute to departmental process improvement initiatives, SOP updates, and quality enhancement activities.
  • Support compliance with company procedures, Good Clinical Practice requirements, and applicable regulatory expectations.

Skills

Analytical skills
Attention to detail
Time management
Communication in English
Cross-functional collaboration
Independent working

Education

Bachelor's degree in Computer Science, Life Sciences, Healthcare, Clinical Research, Data Science, or related field

Tools

Microsoft Office

Job description

Join Clario, a part of Thermo Fisher Scientific and help ensure the quality, accuracy, and integrity of clinical trial data that supports the development of life-changing therapies worldwide. As a Clinical Data Management Associate II within our Medical Imaging business, you will play an important role in reviewing, validating, and managing clinical trial data generated from imaging studies across multiple therapeutic areas. Working closely with project teams, sponsors, and operational stakeholders, you will help drive data quality, support study execution, and contribute to the delivery of reliable clinical data that enables critical research decisions.


What We Offer


  • Competitive pay and incentives.

  • Provident fund and medical insurance.

  • Engaging employee programs and local events.

  • Modern office spaces and remote work flexibility.

  • Opportunities for professional growth and career development within a global organization.


What You'll Be Doing


  • Review study documentation and project requirements to assess impacts on Clinical Data Management processes, standards, and deliverables.

  • Collaborate with cross-functional teams to support study setup, data collection strategies, and evolving project requirements.

  • Support the implementation and execution of data management plans for assigned imaging studies.

  • Define, execute, review, and maintain edit checks to identify discrepancies and ensure high-quality clinical data.

  • Review clinical and imaging-related data to identify inconsistencies, trends, and data quality issues.

  • Develop and maintain study data specifications, including data transfer specifications, system configuration specifications, and data validation requirements.

  • Create, review, and maintain transmittal forms and study documentation while ensuring compliance with established standards.

  • Collaborate with project teams to investigate and resolve data discrepancies and outstanding issues.

  • Track data-related issues through resolution and ensure timely follow-up with relevant stakeholders.

  • Prepare, validate, and deliver ad hoc data listings and study reports as required.

  • Identify system enhancements, bugs, or process improvement opportunities and coordinate communication with appropriate Product Management teams.

  • Maintain complete, accurate, and audit-ready study documentation throughout the study lifecycle.

  • Communicate project status, risks, and data quality concerns to supervisors and project stakeholders.

  • Contribute to departmental process improvement initiatives, SOP updates, and quality enhancement activities.

  • Support compliance with company procedures, Good Clinical Practice requirements, and applicable regulatory expectations.


What We Look For


  • Bachelor's degree in Computer Science, Life Sciences, Healthcare, Clinical Research, Data Science, or a related field preferred, or equivalent professional experience.

  • Minimum 3 or 3+ years of experience in Clinical Data Management, clinical research, biotechnology, pharmaceutical, CRO, or related healthcare environments.

  • Understanding of clinical trial processes, data review methodologies, and clinical database management principles.

  • Working knowledge of relational database concepts, data validation techniques, and quality control processes.

  • Experience developing or maintaining data specifications, edit checks, data transfer requirements, or study configuration documentation preferred.

  • Familiarity with clinical trial terminology and regulated research environments.

  • Proficiency with Microsoft Office applications, including Word, Excel, Access, Outlook, and PowerPoint.

  • Strong analytical and problem-solving skills with the ability to identify and resolve data quality issues.

  • Excellent attention to detail and commitment to data accuracy and quality.

  • Strong organizational, documentation, and time-management skills.

  • Excellent verbal and written communication skills with the ability to communicate effectively in English.

  • Ability to work independently while collaborating effectively within cross-functional and global teams.

  • Professional, proactive, and customer-focused approach with a commitment to continuous improvement.


At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It's a cause that unites and inspires us. It's why we come to work and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.

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