CDE Database Build Lead (Associate Manager)
Job Requisition ID: JR140149
Employment Type: Full Time
Work Mode: Office or Home (Hybrid/Remote)
Locations: Bengaluru, Chennai, Trivandrum – India
Experience Required: 7–10 Years
Job Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a CDE Database Build Lead (Associate Manager) to support the design, development, and governance of clinical data environments. This leadership role is critical to ensuring the accurate build, validation, and delivery of clinical trial databases that enable high-quality data analysis and regulatory submissions.
The successful candidate will provide technical and functional leadership across database build activities, collaborate closely with cross-functional stakeholders, and drive data standards, quality, and compliance across global clinical programs.
Key Responsibilities
Clinical Database Design & Build
Lead the design, development, and validation of clinical databases in alignment with study protocols, data standards, and regulatory requirements.
Oversee the build and review of case report forms (CRFs), edit checks, and data validation rules to ensure data accuracy and consistency.
Cross-Functional Collaboration
Partner with biostatistics, data management, clinical operations, and clinical data science teams to develop data specifications and analysis-ready datasets.
Translate protocol and statistical requirements into robust database designs and implementation strategies.
Data Quality & Compliance
Ensure compliance with industry standards including CDISC (SDTM, ADaM), ICH-GCP, and global regulatory expectations.
Perform and oversee quality control, validation, and documentation activities to support audit and inspection readiness.
Leadership & Mentorship
Provide technical leadership and mentorship to junior programmers and database build specialists.
Support resource planning, workload management, and continuous process improvement initiatives.
Required Qualifications & Experience
Bachelor’s or Master’s degree in Computer Science, Biostatistics, Data Science, Life Sciences, or a related discipline.
Minimum 7 years of experience in clinical data programming or database build activities within a CRO or pharmaceutical environment, including leadership or lead-level responsibilities.
Proven experience in clinical database design, validation, and lifecycle management.
Technical & Functional Skills
Strong proficiency in SAS, R, or other relevant clinical data programming tools.
In-depth knowledge of clinical trial data structures, CRF design, and database build processes.
Hands-on experience with CDISC standards, regulatory submission requirements, and data governance frameworks.
Core Competencies
Strong analytical and problem-solving skills with a focus on data quality and operational excellence.
Excellent communication, stakeholder management, and leadership capabilities.
Ability to manage multiple studies and priorities in a fast-paced, global environment.
Why Join ICON
ICON is committed to building a diverse and inclusive workforce where professionals can thrive and contribute to life-changing clinical research. Employees benefit from competitive compensation, flexible work models, and comprehensive benefits designed to support long-term career growth and personal well-being.
ICON is an equal opportunity employer and maintains a workplace free from discrimination and harassment. All qualified applicants will be considered without regard to race, religion, gender, sexual orientation, disability, or veteran status.
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