Apply in 3 Minutes: Principal Clinical Data Standards Consultant

3 weeks ago

Chennai Bengaluru, India ICON plc Full time

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.

What ICON can offer you:

Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

- Various 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 specialised 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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