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Cde Database Build Lead ( Associate Manager)

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ICON
6-10 years
preferred by company
10 Jan. 12, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.