Logo of Huzzle

Principal Clinical Data Standards Consultant

image

ICON plc

Nov 13, 2024

  • Job
    Full-time
    Senior & Expert Level
  • Research & Development
    Healthcare
  • Madrid
  • Quick Apply

AI generated summary

  • You need a relevant Bachelor's degree, extensive clinical data management experience, proficiency in CDISC standards, strong analytical skills, and excellent communication abilities.
  • You will develop tools for CDISC compliance, define data standards with teams, create training materials, manage data processes, and stay updated on industry trends and regulatory changes.

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.

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.

FAQs

What is the job title for this position?

The job title is Principal Clinical Data Standards Consultant.

Where is the location for this job?

This position is offered across EMEA and can be performed remotely.

What qualifications are required for this role?

A Bachelor's degree in a relevant field is required, with advanced degrees considered a plus.

What experience is needed for this position?

Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry is required.

Are there specific standards that candidates must be proficient in?

Yes, candidates should have advanced proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations such as FDA and EMA.

What responsibilities will the Principal Clinical Data Standards Consultant have?

Responsibilities include developing tools for CDISC compliance, collaborating on data collection strategies, maintaining training materials on standards, managing data management processes, and staying updated on industry trends.

Does ICON provide any employee benefits?

Yes, ICON offers a range of benefits including health insurance, retirement planning, various annual leave entitlements, and access to a global employee assistance program.

Is there an emphasis on diversity and inclusion at ICON?

Yes, ICON is committed to diversity, inclusion, and belonging, fostering a culture that values various perspectives and backgrounds.

Will training materials related to data standards be developed?

Yes, part of the role involves developing and maintaining training and reference materials related to standards topics.

Can I apply if I'm unsure I meet all the requirements?

Yes, ICON encourages you to apply regardless of whether you meet all the requirements, as you may be exactly what they're looking for.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.