CDE Database Build Lead (Associate Manager) – Clinical Data Engineering
Job Requisition ID: JR140149
Employment Type: Full-Time
Work Mode: Office or Home (Hybrid / Remote Options Available)
Locations:
Bengaluru, Karnataka, India
Trivandrum, Kerala, India
Chennai, Tamil Nadu, India
Posted: 7 Days Ago
Job Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced CDE Database Build Lead (Associate Manager) to join its growing Clinical Data Engineering team in India. This role is critical to the design, development, validation, and delivery of high-quality clinical trial databases, supporting global clinical development programs.
The successful candidate will provide technical leadership across database build activities, collaborate with cross-functional stakeholders, and ensure compliance with CDISC standards, regulatory expectations, and internal quality frameworks. This position offers an opportunity to work on complex, global studies within a leading CRO environment.
Key Responsibilities
Lead the end-to-end design, build, and validation of clinical trial databases across multiple studies
Oversee database development activities aligned with study protocols, CRFs, and data management plans
Collaborate closely with Clinical Data Managers, Biostatisticians, Clinical Operations, and Programming teams to define data specifications and timelines
Ensure adherence to CDISC standards (SDTM, ADaM), regulatory requirements, and sponsor expectations
Perform and oversee quality control, UAT support, and database validation activities to ensure data integrity and audit readiness
Provide technical guidance, mentoring, and performance support to junior programmers and database build team members
Support process optimization initiatives and contribute to continuous improvement of clinical data engineering practices
Manage multiple projects simultaneously, ensuring timely and high-quality deliverables
Required Qualifications & Experience
Education:
Bachelor’s or Master’s degree in Computer Science, Life Sciences, Biostatistics, Data Science, or a related discipline
Experience:
6–10 years of experience in clinical data management, database build, or clinical data engineering within a CRO or pharmaceutical environment
Proven experience in a lead or associate manager role handling database build activities for global clinical trials
Technical & Professional Skills:
Strong expertise in clinical database design and build using industry-standard EDC platforms
In-depth knowledge of clinical trial data structures and CDISC standards (SDTM, ADaM)
Hands-on experience with data validation, quality control, and regulatory inspection readiness
Familiarity with SAS, R, or other clinical data programming tools is highly desirable
Excellent analytical, problem-solving, and decision-making skills
Strong communication, leadership, and stakeholder management abilities
Ability to work effectively in cross-functional and global team environments
Why Join ICON?
ICON’s success is driven by its people. The organization is committed to building a diverse, inclusive, and high-performance culture that nurtures talent and rewards excellence. Employees benefit from exposure to global studies, structured career growth, and opportunities to contribute to life-changing therapies.
Compensation & Benefits
ICON offers a competitive salary along with a comprehensive benefits package focused on employee well-being, flexibility, and long-term security, including:
Generous annual leave entitlements
Comprehensive health insurance plans for employees and families
Competitive retirement and savings programs
Global Employee Assistance Programme (TELUS Health) with 24/7 professional support
Life assurance coverage
Country-specific optional benefits such as childcare support, wellness initiatives, gym discounts, travel subsidies, and health assessments
Diversity & Inclusion
ICON is committed to providing an inclusive and accessible workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment. Reasonable accommodations are available for candidates with disabilities throughout the recruitment process.
Application Note
Candidates who do not meet every listed requirement are encouraged to apply. ICON values potential, expertise, and a growth mindset, and this role may lead to broader opportunities within the organization.
Advance your career in clinical data engineering and database leadership with ICON. Apply now through thepharmadaily.com.
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