CDE Database Build Lead (Associate Manager) – Clinical Data Science
Job Type: Full-Time
Work Mode: Hybrid / Office or Home
Locations: Bengaluru, Chennai, Trivandrum, India
Job Requisition ID: JR140149
Industry: Clinical Data Management | Clinical Data Science | CRO
Experience Required: 6–10 Years
About ICON plc
ICON plc is a global leader in healthcare intelligence and clinical research, partnering with pharmaceutical, biotechnology, and medical device organizations to advance innovative therapies. With a strong focus on inclusion, innovation, and operational excellence, ICON supports clinical development programs across the full drug development lifecycle.
At ICON, professionals work in a collaborative, future-focused environment where data-driven insights directly contribute to improving patient outcomes worldwide.
Job Overview
ICON is seeking a CDE Database Build Lead (Associate Manager) to join its Clinical Data Science and Programming function in India. This leadership role is responsible for the design, development, and validation of clinical data environments, supporting global clinical trials and regulatory submissions.
The position requires strong hands-on expertise in clinical data programming, CDISC standards, and database build strategies, along with proven leadership and mentoring capabilities.
Key Responsibilities
Lead the design, development, and validation of clinical data environments (CDEs) for global clinical trials
Drive database build strategies aligned with study protocols, data standards, and regulatory requirements
Collaborate closely with biostatisticians, data managers, clinical teams, and stakeholders to define data specifications and analysis plans
Program and validate clinical datasets, tables, listings, and figures (TLFs) in accordance with study deliverables
Ensure data accuracy, consistency, integrity, and traceability through rigorous quality control and validation checks
Provide technical leadership and mentorship to junior programmers and team members
Manage multiple projects simultaneously while ensuring timelines, quality standards, and compliance are met
Support inspections, audits, and regulatory submissions as required
Required Qualifications & Experience
Education:
Bachelor’s or Master’s degree in Computer Science, Data Science, Biostatistics, Statistics, or a related scientific discipline
Experience:
6–10 years of experience in clinical data programming or clinical data science
Prior experience in a Lead or Associate Manager role is preferred
Technical & Professional Skills
Strong hands-on expertise in SAS, R, or other relevant clinical programming languages
In-depth knowledge of clinical trial data structures and CDISC standards (SDTM, ADaM)
Solid understanding of regulatory requirements for clinical trials and submissions
Proven ability to lead database build activities across multiple studies
Strong analytical, problem-solving, and quality-focused mindset
Excellent communication, stakeholder management, and leadership skills
Why Join ICON
Work with a globally recognized CRO on cutting-edge clinical research programs
Hybrid work flexibility with location options across major Indian cities
Competitive compensation and comprehensive benefits package
Career growth through leadership development and global project exposure
Inclusive workplace culture focused on well-being, performance, and innovation
Diversity, Equity & Inclusion
ICON is committed to building an inclusive and accessible workplace. Employment decisions are made without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations are available throughout the hiring process.
Career Growth & Opportunity
If you are passionate about clinical data science, database build leadership, and regulatory-quality delivery, this role offers the opportunity to grow into senior leadership positions within ICON’s global clinical development ecosystem.
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Siliguri |Illinois :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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