Principal Clinical Data Standards Consultant – Office-Based | Bangalore / Chennai
Job Summary:
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Principal Clinical Data Standards Consultant to join their expert team in Bangalore or Chennai (office-based). This is a strategic role that supports clinical trial data quality and regulatory compliance through the development and oversight of data standards such as CDISC, SDTM, ADaM, and Define-XML. If you bring deep experience in clinical data management and are passionate about shaping global data governance practices, this is your opportunity to lead impactful innovation in the life sciences industry.
Key Responsibilities:
Develop tools and frameworks to implement CDISC, ICON, and Sponsor data standards.
Define and maintain strategies for data collection and standardization in clinical trials.
Author and update training/reference materials for CDASH, SDTM, ADaM, and regulatory submissions.
Collaborate with cross-functional teams to integrate evolving regulatory and data requirements.
Lead updates to data management processes and ensure standards are aligned with industry best practices.
Stay updated on global health authority guidelines (FDA, EMA) and incorporate changes into internal practices.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Computer Science, or related field (Master’s preferred).
Extensive experience in clinical data management and data standards within pharma or biotech.
Proven expertise in CDISC standards including SDTM, ADaM, Define-XML, and related terminologies.
Deep understanding of regulatory compliance frameworks (FDA, EMA).
Strong analytical and technical skills with attention to detail.
Effective communication and leadership abilities, particularly in cross-functional environments.
Perks & Benefits:
Competitive base salary and performance-linked rewards.
Flexible leave policies and robust health insurance coverage.
Global Employee Assistance Programme (LifeWorks) for 24/7 mental and emotional support.
Retirement planning options tailored to local markets.
Optional benefits including gym subsidies, bike schemes, and childcare support.
A work culture rooted in inclusion, collaboration, and talent development.
Company Description:
ICON plc is a leading global provider of clinical research and healthcare intelligence services, delivering data-driven solutions to the pharmaceutical, biotechnology, and medical device sectors. ICON’s mission is to accelerate clinical development and transform patient outcomes through excellence, innovation, and commitment to regulatory standards.
Work Mode:
Office-Based – Bangalore or Chennai
Call-to-Action:
Are you ready to set the benchmark for data quality in global clinical trials? Apply now to become a Principal Clinical Data Standards Consultant at ICON and help lead the future of clinical research.
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