Principal Clinical Data Standards Consultant
3 weeks ago
Job Description
What you will be doingAs a Senior Clinical Data Standards Consultant at ICON Plc, you will be responsible for:
- 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 ICONs practices.
Your profileTo excel in this role, you should possess the following qualifications and attributes:
- A Bachelors 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 biotechNlogy 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.
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