Senior Clinical Data Standards Specialist

hace 3 semanas


Madrid, Madrid, España Icon Plc A tiempo completo
Job Description

About ICON plc:

We are a world-leading healthcare intelligence and clinical research organization, fostering an inclusive environment that drives innovation and excellence.

About the Role:

We seek a Senior Clinical Data Standards Specialist to join our team. As a key member of our clinical data management department, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing 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, ensuring seamless data collection and analysis.
  • Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials, driving operational efficiency and quality.
  • Creating and maintaining training and reference materials related to standards topics, including CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
  • Managing the development and maintenance of data management processes and tools, guaranteeing scalability and adaptability.
  • Staying up-to-date with industry trends and regulatory updates related to data standards, ensuring their integration into ICON's practices.

Requirements:

  • 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:

In addition to your competitive salary of $120,000 - $150,000 per annum, we offer a range of benefits focused on well-being and work-life balance opportunities for you and your family.

Benefits Include:

  • Varying annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.


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