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Senior Clinical Data Management Specialist

2 months ago

London, Greater London, United Kingdom ICON Plc Full time
Job Description

At ICON Plc, we are seeking a highly skilled Principal Clinical Data Standards Consultant to join our team. As a key member of our clinical data management team, 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
  • Develop and Implement Data Standards: Design and develop tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.
  • Collaborate with Cross-Functional Teams: Work closely with cross-functional teams to define data collection strategies and standards for clinical trials.
  • Develop Training and Reference Materials: Create and maintain training and reference materials related to standards topics, including CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
  • Manage Data Management Processes: Oversee the development and maintenance of data management processes and tools.
  • Stay Up-to-Date with Industry Trends: Keep abreast of industry trends and regulatory updates related to data standards and ensure their integration into ICON's practices.
Requirements
  • Education: Bachelor's degree in a relevant field, such as Life Sciences, Computer Science, or a related discipline. Advanced degrees are a plus.
  • Experience: Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.
  • Skills: Advanced proficiency in CDISC standards and relevant regulations, excellent analytical and problem-solving skills, and excellent communication and collaboration abilities.
What We Offer
  • Competitive Salary: A competitive salary and benefits package.
  • Opportunities for Growth: Opportunities for career growth and professional development.
  • Diverse and Inclusive Environment: A diverse and inclusive work environment that values and respects all employees.