Senior Clinical Data Standards Specialist
hace 3 semanas
About ICON plc:
We are a world-leading healthcare intelligence and clinical research organization, fostering an inclusive environment that drives innovation and excellence.
About the Role:
We seek a Senior Clinical Data Standards Specialist to join our team. As a key member of our clinical data management department, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
Key Responsibilities:
- Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards, ensuring seamless data collection and analysis.
- Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials, driving operational efficiency and quality.
- Creating and maintaining training and reference materials related to standards topics, including CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
- Managing the development and maintenance of data management processes and tools, guaranteeing scalability and adaptability.
- Staying up-to-date with industry trends and regulatory updates related to data standards, ensuring their integration into ICON's practices.
Requirements:
- 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 biotechnology 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 We Offer:
In addition to your competitive salary of $120,000 - $150,000 per annum, we offer a range of benefits focused on well-being and work-life balance opportunities for you and your family.
Benefits Include:
- Varying 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 specialized 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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