Senior Clinical Data Coordinator Clinical Data Management

Why This Role Matters

At ICON plc, high-quality clinical data is the backbone of every successful clinical trial. Accurate and compliant data ensures that regulatory submissions are reliable, patient safety is maintained, and scientific conclusions are valid.
The Senior Clinical Data Coordinator plays a vital role in safeguarding data integrity throughout the study lifecycle. From database setup to final database lock, this position ensures that every data point collected is accurate, verified, and audit-ready. This role directly supports the development of innovative therapies and contributes to global healthcare advancement.

Job Description

The Senior Clinical Data Coordinator is responsible for planning, coordinating, and executing clinical data management activities across assigned studies. The role ensures compliance with industry standards and regulatory requirements while maintaining high levels of data accuracy and operational efficiency.
Working closely with cross-functional teams such as clinical operations, biostatistics, and medical affairs, the Senior CDC ensures seamless data flow and timely project delivery. This role also includes mentoring junior team members and supporting quality improvement initiatives.

Key Features of the Role

• Strategic involvement in clinical data lifecycle management
• Collaboration with global cross-functional teams
• Leadership and mentoring responsibilities
• Exposure to regulatory-compliant clinical trial processes
• Contribution to pharmaceutical and biotechnology research projects

Responsibilities

• Develop and maintain comprehensive Data Management Plans aligned with study protocols.
• Ensure accurate setup and maintenance of clinical databases.
• Identify and resolve data discrepancies through efficient query management.
• Perform data validation and cleaning before interim analysis and database lock.
• Coordinate with investigator sites to streamline data collection and flow.
• Collaborate with biostatistics teams to prepare high-quality datasets.
• Maintain audit-ready documentation for regulatory inspections.
• Mentor junior data coordinators in coding, reconciliation, and cleaning processes.
• Support filing, archiving, and documentation to meet study timelines.
• Contribute to continuous improvement initiatives in data management processes.

Required Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, Biotechnology, or related field.
• Proven experience in clinical data management within pharmaceutical, CRO, or biotech industries.
• Strong understanding of clinical trial processes and regulatory standards.

Educational Requirements

• Bachelor’s degree (mandatory) in a scientific or healthcare discipline.
• Additional certifications in clinical research or data management are advantageous.

Experience and Skills

• Hands-on experience with clinical data systems such as Medidata Rave, Oracle RDC, or similar platforms.
• Knowledge of ICH-GCP and global regulatory guidelines.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organizational ability.
• Effective communication and collaboration skills.
• Ability to manage multiple studies in a fast-paced environment.
• Leadership capability to mentor junior team members.

Salary Insights

Compensation is competitive and aligned with industry benchmarks. Salary packages depend on:

• Years of experience
• Technical expertise in clinical data management systems
• Exposure to global trials
• Leadership and mentoring experience

ICON also provides comprehensive benefits designed to support employee well-being and work-life balance.

Company Overview

ICON plc is a global healthcare intelligence and clinical research organization dedicated to accelerating clinical development through innovation and operational excellence.
With a strong global presence, ICON partners with pharmaceutical and biotechnology companies to deliver high-quality clinical research solutions. The organization promotes diversity, inclusion, and professional growth while maintaining the highest standards of regulatory compliance and ethical conduct.

FAQs

1. What is the primary responsibility of a Senior Clinical Data Coordinator?
   Overseeing data management activities to ensure accuracy, compliance, and readiness for analysis and regulatory submission.

2. Is prior data management experience mandatory?
   Yes, relevant industry experience is required.

3. What software knowledge is preferred?
   Experience with Medidata Rave, Oracle RDC, or equivalent clinical data systems is preferred.

4. Is regulatory knowledge important?
   Yes, familiarity with ICH-GCP guidelines is highly valuable.

5. Does the role include mentoring?
   Yes, mentoring junior team members is part of the responsibility.

Application Tips

• Highlight practical experience with clinical data systems.
• Demonstrate knowledge of regulatory compliance and GCP standards.
• Provide examples of query resolution and database lock participation.
• Emphasize leadership or mentoring contributions.
• Showcase ability to manage timelines across multiple studies.