ICON plc, a global leader in healthcare intelligence and clinical research, is inviting talented professionals to join their team as Principal Clinical Data Standards Consultants. With a mission to drive innovation and excellence in clinical development, ICON is committed to fostering an inclusive workplace that values diversity and collaboration. This role is based in Bangalore, India, with additional opportunities available in London, UK.
About ICON
ICON plc is at the forefront of clinical research and healthcare solutions, providing cutting-edge expertise to shape the future of clinical development. ICON’s commitment to innovation, talent development, and inclusion ensures the delivery of impactful therapies and treatments for patients worldwide.
Responsibilities of a Principal Clinical Data Standards Consultant
As a pivotal member of ICON’s team, you will:
- Standards Implementation:
- Develop tools and resources to ensure compliance with CDISC (Clinical Data Interchange Standards Consortium), sponsor, and ICON standards.
- Data Collection Strategy:
- Collaborate with cross-functional teams to define data collection strategies and clinical trial standards.
- Training and Reference Development:
- Create and maintain training materials on CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
- Process Management:
- Oversee the development and maintenance of data management processes and tools.
- Industry and Regulatory Updates:
- Stay updated on industry trends and regulatory changes, integrating them into ICON’s practices.
Qualifications and Skills Required
To excel in this role, the following qualifications and skills are essential:
- Education:
- A Bachelor’s degree in Life Sciences, Computer Science, or a related field. Advanced degrees are a plus.
- Experience:
- Extensive experience in clinical data management and standards, particularly in the pharmaceutical or biotechnology industry.
- Technical Proficiency:
- Expertise in CDISC standards and regulatory frameworks (e.g., FDA, EMA).
- Analytical Skills:
- Strong problem-solving abilities with an eye for detail.
- Collaboration:
- Excellent communication and teamwork skills to thrive in cross-functional environments.
What ICON Offers
ICON prioritizes the well-being and development of its employees. Here’s what you can expect:
- Work-Life Balance:
- Generous annual leave entitlements and flexible working options.
- Health and Wellness:
- Comprehensive health insurance plans and access to a global employee assistance program.
- Retirement Planning:
- Competitive retirement benefits to plan confidently for the future.
- Additional Perks:
- Subsidized travel, childcare vouchers, gym memberships, and more country-specific benefits.
