Senior Clinical Data Science Lead
Company: ICON plc
Locations: Bangalore, Chennai, Trivandrum (India)
Work Mode: Office or Home (Hybrid/Remote)
Department: Clinical Data Management / Clinical Data Science
Employment Type: Full-Time
Experience: 6–10 years of experience in Clinical Data Management or Clinical Data Science, including leadership of clinical trials, eCRF design, database management, vendor oversight, and regulatory compliance.
Salary Package: ₹18–28 LPA (Approx., based on current market standards; final compensation depends on candidate experience, leadership skills, and clinical data management expertise.)
Role Overview
The Senior Clinical Data Science Lead is responsible for leading Clinical Data Management activities across one or more clinical trials, ensuring high standards of data quality, integrity, regulatory compliance, and timely delivery of study milestones. The role partners with global cross-functional teams, manages data management strategies, oversees vendors, and drives inspection readiness throughout the clinical trial lifecycle.
Key Responsibilities
Clinical Data Management Leadership
Lead and oversee Clinical Data Management activities across multiple clinical trials.
Develop and execute data management strategies aligned with study objectives.
Ensure timely delivery of all clinical data management milestones.
Drive operational excellence throughout the clinical trial lifecycle.
Data Collection & Database Management
Gather and define business requirements for:
Electronic Case Report Forms (eCRFs)
Data collection tools
Clinical databases
Ensure consistency in data collection standards, conventions, and dataset structures.
Support database development, release planning, and maintenance activities.
Ensure high-quality, accurate, and complete clinical trial data.
Clinical Data Quality & Compliance
Ensure compliance with:
ICH-GCP Guidelines
Regulatory requirements
Company SOPs
Work Instructions
Industry best practices
Maintain continuous inspection readiness.
Support internal audits, sponsor audits, and regulatory inspections.
Ensure data management documentation meets quality and compliance standards.
Project Planning & Delivery
Plan, monitor, and deliver key Clinical Data Management deliverables, including:
CRFs/eCRFs
Data Review Plans
Quality Control (QC) Plans
Oversight Plans
Database Release Plans
Final Clinical Datasets
Track project timelines and proactively manage risks.
Ensure project milestones are achieved within agreed timelines.
Cross-Functional Collaboration
Act as the primary point of contact for Clinical Data Management activities.
Collaborate with:
Clinical Operations
Biostatistics
Medical Writing
Regulatory Affairs
Clinical Data Management teams
External vendors
Participate in global cross-functional working groups.
Align project expectations, deliverables, and timelines across stakeholders.
Vendor & Stakeholder Management
Manage relationships with external vendors and service providers.
Monitor vendor performance and ensure quality deliverables.
Coordinate project activities across global and multicultural teams.
Communicate project status and data management updates to stakeholders.
Leadership & Continuous Improvement
Provide leadership, mentoring, and technical guidance to Clinical Data Management teams.
Share best practices and conduct knowledge-sharing sessions.
Deliver training programs for team members.
Drive process improvements and operational excellence initiatives.
Educational Qualification
Bachelor's degree in:
Life Sciences
Health Sciences
Pharmacy
Biotechnology
Or another related discipline
Required Experience
6–10 years of experience in Clinical Data Management or Clinical Data Science.
Experience managing multiple clinical trials in pharmaceutical, biotechnology, or CRO environments.
Proven experience leading cross-functional and global clinical projects.
Experience in vendor management and project leadership.
Strong understanding of clinical trial data standards and regulatory requirements.
Technical Skills
Expertise in Clinical Data Management processes and systems.
Hands-on experience with:
Electronic Data Capture (EDC) systems
eCRF development
Clinical databases
Data review and validation
Database release planning
Strong knowledge of:
ICH-GCP Guidelines
Clinical trial regulations
Data quality and compliance standards
Advanced proficiency in Microsoft Office, including Excel for data analysis.
Experience interpreting clinical data and generating actionable insights.
Key Competencies
Strong leadership and team management skills.
Excellent project planning and organizational abilities.
Strong analytical and problem-solving capabilities.
Excellent stakeholder and vendor management skills.
Effective communication and presentation abilities.
High attention to detail with a quality-focused mindset.
Ability to work in global, cross-functional, and multicultural environments.
Commitment to continuous improvement and operational excellence.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Netherlands |Remote Australia :
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Witney |Ontario :
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Argentina | Peru |Brazil :
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Tallinn |Hà Nội :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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