Principal Clinical Data Standards Consultant

ICON plc

5 - 11 years

2 - 13 Lacs

bengaluru karnataka india

Posted:5 days ago| Platform: Foundit logo

Apply

Skills Required

collaboration cross functional team clinical data management

Work Mode

On-site

Job Type

Full Time

Job Description

What you will be doing

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 profile

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.

More Jobs at ICON plc

Biostatistician I & II

Bengaluru, Karnataka

2 - 2 yrs

Salary: Not disclosed

CDC II

Bengaluru, Karnataka

Experience: Not specified

Salary: Not disclosed

CTA

Bengaluru, Karnataka

Experience: Not specified

Salary: Not disclosed

CDC II

Bengaluru, Karnataka

Experience: Not specified

Salary: Not disclosed

Project Assistant Imaging

Thiruvananthapuram, Kerala

Experience: Not specified

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.