ICON plc
ICON plc is a leading global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They specialize in a full range of services, including clinical trial management, regulatory affairs, and patient recruitment, aiming to advance the development of transformative therapies across various sectors. ICON employs innovative technology and data solutions to streamline the drug development process and ensure effective clinical outcomes for patients.
Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes
External Data Services Manager
March 19
ICON plc
ICON plc is a leading global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They specialize in a full range of services, including clinical trial management, regulatory affairs, and patient recruitment, aiming to advance the development of transformative therapies across various sectors. ICON employs innovative technology and data solutions to streamline the drug development process and ensure effective clinical outcomes for patients.
Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes
📋 Description
• The Manager, Data Management - External Data Services will play a critical role in Clinical Development through ensuring the delivery of appropriately structured external data. • The Manager, External Data Services will be responsible for effectively leading and supporting the Global Development Data Management team.
🎯 Requirements
• Minimum of 8 years of external clinical data management/programming experience in biotechnology, pharmaceutical or health related industry and strong knowledge of database structures. • Expertise in biomarker data types and/or Imaging data for oncology and non-oncology studies is preferred • Experience working with multiple data types/formats • Experience in managing clinical, biomarker data, eCOA and imaging data • Demonstrates broad knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data • Demonstrates advanced knowledge of Data Management processes and industry best practices. • Advanced knowledge and experience with extracting data into SAS, CSV, and XML formats is required • BS Major/ Minor (Biology, Computer Science, programming, data management, scientific or analytic discipline or equivalent)
🏖️ Benefits
• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs • Competitive retirement planning offerings to maximise 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 specialised 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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