Lead Clinical Data Standards Specialist

Há 2 dias


Lisboa, Lisboa, Portugal Icon Plc Tempo inteiro

Job Summary:

We are seeking a Clinical Trials Data Management Expert to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization.

About the Role:

This is an exciting opportunity to design and analyze clinical trials, interpret complex medical data, and contribute to the advancement of innovative treatments and therapies.

Key Responsibilities:

  • Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.
  • Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.
  • Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, TermiNlogy, ADaM, define-XML, and regulatory submission requirements.
  • Managing the development and maintenance of data management processes and tools.
  • Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.

Your Profile:

  • A 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 (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).
  • Excellent analytical and problem-solving skills with a keen attention to detail.
  • Excellent communication and collaboration abilities to work effectively in cross-functional teams.

What We Offer:

  • A competitive salary range of $90,000 - $120,000 per year, depending on experience.
  • A range of benefits, including annual leave entitlements, health insurance, retirement planning, and flexible country-specific optional benefits.
  • A global Employee Assistance Programme, TELUS Health, offering 24-hour access to a network of professionals who support well-being.
  • A commitment to diversity, inclusion & belonging, fostering a culture that rewards high performance and nurtures talent.

How to Apply:

Please visit our careers site for more information and to submit your application.



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