Principal Clinical Data Standards Consultant

ICON plc

5 - 11 years

2 - 13 Lacs

bengaluru karnataka india

Posted:5 days ago| Platform: Foundit logo

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Skills Required

problem solving clinical data biotechnology

Work Mode

On-site

Job Type

Full Time

Job Description

Principal Clinical Data Standards ConsultantBengaluruOffice based
ICON plc is a world-leading healthcare intelligence and clinical research organization
Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Principal Clinical Data Standards Consultant to join our diverse and dynamic team
As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies
What You Will Be Doing
As 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 ICON's practices
Your profile
To excel in this role, you should possess the following qualifications and attributes:
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 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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