Clinical Data Management Specialist

Why This Role Matters

Clinical Data Management is a critical component of modern clinical research, ensuring that data generated during clinical trials is accurate, reliable, and compliant with global regulatory standards. Proper management of clinical trial data helps researchers evaluate treatment safety and effectiveness while supporting regulatory approvals for new therapies. The Clinical Data Coordinator II role at ICON plc plays a vital part in supporting clinical trials by maintaining data quality, managing electronic case report forms, and coordinating data validation processes. Professionals in this role help ensure that clinical trial datasets are complete, accurate, and ready for statistical analysis.
Working within a global clinical research environment, this position supports clinical data scientists and project teams in identifying and resolving data issues, reconciling study data, and maintaining compliance with international regulatory standards. For experienced professionals in clinical data management, this role offers an opportunity to contribute to the development of innovative therapies while working in a fast-paced and collaborative clinical research environment.

Job Description

ICON plc is seeking a Clinical Data Coordinator II to join its clinical data management team in Bangalore, India. The selected candidate will support clinical trial data operations by assisting with electronic case report form maintenance, managing clinical data reconciliation, and ensuring the accuracy and integrity of study datasets. The role involves collaborating with clinical data scientists, project teams, and functional management to track study progress and address data-related issues. The Clinical Data Coordinator II will also contribute to maintaining data validation specifications and study-specific procedures while ensuring that all clinical trial data complies with regulatory requirements and company standards.

Key Features of the Role

Opportunity to work in global clinical trial data management
Involvement in clinical trial data analysis and validation processes
Collaboration with clinical data scientists and cross-functional research teams
Exposure to electronic data capture systems used in clinical trials
Participation in maintaining data integrity and regulatory compliance
Contribution to the development of innovative treatments and therapies

Responsibilities

Clinical Data Management Support
Assist the Data Management Study Lead in maintaining electronic case report forms and ensuring that study documentation remains updated throughout the clinical trial process. Support the development and maintenance of data validation specifications and study-specific procedures.

Data Review and Reconciliation
Manage reconciliation of clinical and third-party data based on predefined edit specifications and data review plans. Ensure that discrepancies are identified and resolved to maintain high-quality clinical trial datasets.

Study Metrics and Reporting
Track and communicate the status of study tasks and key metrics to clinical data scientists, project teams, and functional management. Provide updates on study progress and data-related activities.

Data Issue Resolution
Address data-related queries and recommend appropriate solutions to maintain data accuracy. Investigate root causes of data issues and implement corrective measures to prevent recurrence.

Collaboration and Communication
Work closely with cross-functional teams including clinical research professionals, data scientists, and project managers to ensure efficient data management processes across clinical studies.

Required Qualifications

Educational Requirements

Bachelor’s degree in Life Sciences, Healthcare, or a related scientific discipline.

Experience and Skills

Minimum of 5 years of relevant experience in clinical data management within the pharmaceutical, biotechnology, or clinical research industry. Strong understanding of clinical trial data processes and electronic data capture systems.

Technical Knowledge

Familiarity with clinical data management platforms such as Medidata Rave and Oracle Clinical Remote Data Capture or similar systems used in clinical research environments. Understanding of global regulatory standards including Good Clinical Practice is considered advantageous.

Professional Skills

Strong attention to detail and the ability to manage complex clinical datasets. Excellent communication skills and the ability to collaborate effectively with cross-functional teams in a fast-paced clinical research environment. Ability to analyze clinical data issues and implement systematic solutions to maintain data quality.

Salary Insights

Although the exact salary package has not been disclosed, Clinical Data Management roles in global clinical research organizations typically offer competitive compensation based on experience, expertise, and company policies. Additional benefits may include healthcare coverage, retirement planning programs, and employee wellness initiatives.

Company Overview

ICON plc is a global clinical research organization that provides healthcare intelligence and clinical development services to pharmaceutical, biotechnology, and medical device companies. The company specializes in clinical trial management, data analysis, and regulatory support to accelerate the development of new medicines and therapies. Through its global network of research professionals, ICON helps bring innovative treatments to patients while maintaining high standards of scientific excellence and regulatory compliance.
ICON promotes an inclusive work culture that encourages innovation, collaboration, and professional development, enabling employees to contribute to meaningful advancements in healthcare and clinical research.

FAQs

Who can apply for this role?
Candidates with a bachelor’s degree in Life Sciences or a related field and relevant experience in clinical data management.

How much experience is required?
Applicants should have approximately five years of experience in clinical data management within pharmaceutical or biotechnology industries.

What tools are commonly used in this role?
Clinical data management systems such as Medidata Rave, Oracle RDC, or other electronic data capture platforms are commonly used.

Does the role involve working with clinical trials?
Yes. The position supports data management activities for clinical trials and ensures data quality throughout the study lifecycle.

Application Tips

Highlight your experience in clinical data management and electronic data capture systems.
Mention any experience working with Medidata Rave, Oracle RDC, or similar data management platforms.
Demonstrate familiarity with clinical trial data review processes and reconciliation activities.
Emphasize knowledge of regulatory standards such as ICH-GCP.
Showcase your ability to collaborate with multidisciplinary clinical research teams.