ICON plc
ICON plc
ICON plc je globalna pogodbena raziskovalna organizacija, ki zagotavlja storitve za zdravstveno in farmacevtsko industrijo. Njeno delo vključuje klinične, svetovalne in komercialne storitve, ki podpirajo razvoj zdravil od zgodnjih raziskav do dejavnosti po prihodu na trg. Podjetje ponuja rešitve, kot so decentralizirane klinične raziskave, ocenjevanje srčne varnosti, laboratorijske storitve za zgodnje klinične raziskave, medicinsko slikanje, regulatorne informacije in dokazi iz resničnega sveta. ICON plc ima tudi terapevtsko strokovno znanje na področjih, kot so bolezni srca in ožilja, onkologija, interna medicina, celične in genske terapije ter podobna biološka zdravila, pri čemer združuje analizo podatkov s pristopi, osredotočenimi na paciente, da pomaga napredovati klinične programe.

Senior Clinical Data Manager, Data Standards

Lead clinical data standards, quality, and governance for ICON’s sponsor-dedicated trials. Improve global processes and coordinate delivery across teams.

Opis

  • Lead the development and implementation of clinical data standards processes and best practices.
  • Drive work on data cleaning, data quality, edit checks, data listings, and standards library management.
  • Work closely with Clinical Trial Reporting (CTR), Clinical Trial Configuration (CTC), and Cross-Functional Data Review (CFDR) teams.
  • Set governance, workflows, and quality standards that support clinical trial delivery.
  • Lead and mentor Associate Manager-level colleagues and encourage continuous improvement.
  • Work with cross-functional stakeholders to turn strategic objectives into operational plans.
  • Identify risks, improve processes, and advance data quality throughout the clinical data lifecycle.

Zahteve

  • Hold a bachelor’s degree in life sciences, health sciences, or a related field.
  • Bring extensive clinical data management experience from a CRO, biotechnology, or pharmaceutical setting.
  • Have strong experience in process development, project management, stakeholder engagement, and cross-functional collaboration.
  • Show a proven ability to build and implement new processes and ways of working.
  • Have experience with data quality, standards development, data review, edit checks, data listings, or standards library management.
  • Understand clinical trial processes, regulatory requirements, and ICH-GCP.
  • Demonstrate strong communication, problem-solving, and leadership skills.
  • Bring an entrepreneurial outlook and the ability to thrive in a developing, evolving function.
  • Have legal authorization to work in the country where the role is based.

Ugodnosti

  • Competitive base pay with performance-related incentives.
  • Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
  • Retirement and pension plans.
  • Life assurance and disability coverage.
  • Employee assistance programmes and wellbeing resources.
  • Learning and development through structured training and career pathways.

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