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Principal Clinical Data Standards Consultant

2+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time 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

Job Title: Principal Clinical Data Standards Consultant

Location: Bangalore, India

Company: ICON plc

About Us: ICON plc is a leading healthcare intelligence and clinical research organization committed to shaping the future of clinical development. We foster an inclusive environment that drives innovation and excellence, and we invite you to join our dynamic team.

Position Overview: As a Principal Clinical Data Standards Consultant at ICON, you will be instrumental in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Key Responsibilities:

  • Develop tools for the implementation and compliance of CDISC, Sponsor, and ICON standards.
  • Collaborate with cross-functional teams to define data collection strategies and standards for clinical trials.
  • Create and maintain training and reference materials related to standards topics, including CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
  • Manage the development and maintenance of data management processes and tools.
  • Stay updated on industry trends and regulatory changes related to data standards and ensure their integration into ICON's practices.

Your Profile:

  • Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, or related discipline); advanced degrees are a plus.
  • Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.
  • Advanced proficiency in CDISC standards and relevant regulations (e.g., FDA, EMA).
  • Excellent analytical and problem-solving skills with strong attention to detail.
  • Strong communication and collaboration abilities to work effectively in cross-functional teams.

What ICON Can Offer You: At ICON, our success depends on the quality of our people. We prioritize a diverse culture that rewards high performance and nurtures talent. In addition to competitive salaries, we offer:

  • Various annual leave entitlements.
  • A range of health insurance offerings tailored to you and your family.
  • Competitive retirement planning options.
  • Global Employee Assistance Programme providing 24-hour access to a global network of specialists.
  • Life assurance and flexible optional benefits, including childcare vouchers and discounted gym memberships.

For more details about our benefits, visit our careers site.

Diversity and Inclusion: ICON is an equal opportunity employer committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you need reasonable accommodations during the application process, please let us know through the form below.

Interested but Unsure? If you’re interested in this role but don’t meet all the requirements, we encourage you to apply—there’s a chance you might be exactly what we’re looking for!

Current ICON Employees: If you are a current ICON employee, please click here to apply.