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Principal Clinical Data Standards Consultant

0-2 years
Not Disclosed
10 April 17, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Job Title: Principal Clinical Data Standards Consultant

Locations: Bangalore, Chennai, Bengaluru
Job ID: JR128621
Department: Data Standards Consultant
Division: ICON Full Service & Corporate Support
Work Type: Hybrid (Office/Remote)
Hiring Manager: Ekta Chandra Srivastava
Actions: Apply | Shortlist | Send a Message to Hiring Manager


About the Role

ICON plc, a global leader in clinical research and healthcare intelligence, is seeking a Principal Clinical Data Standards Consultant for its Bengaluru location. This position offers an exciting opportunity to lead data standards initiatives, support innovation in clinical data collection, and play a strategic role in transforming clinical development practices.


Key Responsibilities

  • Develop tools to ensure compliance with CDISC, Sponsor, and ICON standards

  • Define and implement data collection strategies in collaboration with cross-functional teams

  • Create and maintain training/reference materials for CDASH, SDTM, ADaM, Define-XML, terminology, and regulatory submissions

  • Oversee the development and enhancement of clinical data management processes and tools

  • Stay current with regulatory and industry trends, incorporating updates into ICON’s practices


Candidate Profile

  • Bachelor’s degree in Life Sciences, Computer Science, or related field (advanced degrees preferred)

  • Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry

  • Strong expertise in CDISC standards and regulatory expectations (e.g., FDA, EMA)

  • Excellent analytical, organizational, and problem-solving skills

  • Effective communicator with a collaborative mindset to work across global teams


What ICON Can Offer You

ICON prioritizes your career growth and well-being. In addition to a competitive salary, you’ll receive a robust package of benefits tailored to promote a healthy work-life balance.

Sample Benefits Include:

  • Various annual leave entitlements

  • A range of family-friendly health insurance plans

  • Competitive retirement savings plans

  • Access to LifeWorks Global Employee Assistance Programme

  • Life assurance

  • Country-specific optional benefits (e.g., childcare vouchers, cycle-to-work schemes, gym discounts, health checks, subsidized travel)

Learn more about benefits: ICON Careers - Benefits


Inclusion & Accessibility

ICON is committed to building an inclusive culture where everyone can thrive.
We provide equal employment opportunities and will make reasonable accommodations for candidates with disabilities.

Details: ICON Reasonable Accommodations


Encouragement to Apply

Not sure if you meet every requirement? That’s okay. ICON encourages all qualified applicants to apply—you could be just who we’re looking for.


Contact the Hiring Manager

Name: Ekta Chandra Srivastava
Actions: View other roles | Send a direct message

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