Principal Clinical Data Science Lead

Icon • Blue Bell, PA

288d

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We have an incredible opportunity for a Principal Clinical Data Science Lead (CDSL) to join ICON's Full Service Early Phase Clinical Data Science team. The Principal CDSL is responsible for managing clinical data science teams, studies, and programs of studies. The Principal CDSL will provide planning estimates for project scope, schedule, and resource requirements, and ensures that studies are properly managed and delivered. The Early Phase service line of the company specializes in the strategic development, management, and analysis of studies and programs that support Phase 1/2a clinical development.

Requirements

• 6+ years of clinical data management experience (in a Clinical Research Organization or Pharmaceutical company).
• 3+ years of experience leading studies with key responsibilities for study set-up and close-out tasks.
• Experience with Phase I studies strongly preferred, but not required.
• Experience with Rave strongly preferred, but must have experience with at least one of ICON's preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC).
• Highly computer literate, including strong Microsoft Office skills.
• Excellent communication and interpersonal skills.
• Strong client relationship management skills.
• Excellent organizational and planning skills as well as a demonstrated aptitude for project management.
• Bachelor's degree or local equivalent in a scientific field and/or equivalent experience.

Responsibilities

• Manage a number of fast-moving early phase studies or programs of studies to ensure project objectives are met within budget, to agreed timelines, and to a high level of quality.
• Manage a global team of clinical data management resources.
• Provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and any other study related documents.
• Responsible for the maintenance, cleaning, and lock of the EDC study databases.
• Review the project contract to ensure that any out-of-scope work is managed promptly and efficiently.
• Manage the overall project budget throughout the life cycle of the project, taking overall responsibility for cost control, timelines, and project quality.
• Negotiate with clients and/or external customers/departments in relation to timelines and key deliverables.
• Work with Clinical Operations, Biostatistics, SAS Programming, Medical Writing, and Quality Assurance to ensure that data collected during trials is managed according to corporate standards and meets regulatory guidelines for data integrity.

Benefits

• Various 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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree