Clinical Data Standards Expert
1 semana atrás
At ICON Plc, a world-leading healthcare intelligence and clinical research organization, we're shaping the future of clinical development. We foster an inclusive environment driving innovation and excellence. Our mission is to advance innovative treatments and therapies. As a Principal Clinical Data Standards Consultant, you'll play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to our advancement. We welcome candidates from across EMEA.
About the RoleWe're seeking a skilled expert to join our diverse and dynamic team. Your primary responsibilities will include:
- Developing tools for implementing and complying with CDISC, Sponsor, and ICON standards
- Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials
- Maintaining training and reference materials related to standards topics, including CDASH, SDTM, TermiNlogy, ADaM, define-XML, and regulatory submission requirements
- Managing data management processes and tools
- Staying up-to-date with industry trends and regulatory updates, ensuring their integration into ICON's practices
To be successful in this role, you'll need:
- 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 standards and relevant regulations (e.g., FDA, EMA)
- Excellent analytical and problem-solving skills with attention to detail
- Effective communication and collaboration abilities to work in cross-functional teams
We value our people and offer a range of benefits to support your well-being and work-life balance. You can expect:
- Competitive salary: £85,000 - £110,000 per annum, depending on location and experience
- Various annual leave entitlements
- Range of health insurance offerings
- Competitive retirement planning
- Global Employee Assistance Programme
- Life assurance
- Flexible country-specific optional benefits
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