Senior Clinical Data Management Director

Há 1 mês


Lisboa, Lisboa, Portugal Icon Plc Tempo inteiro
Job Title:

Senior Clinical Data Management Director

About ICON Plc:

ICON plc is a leading global healthcare intelligence and clinical research organization. We strive to create an inclusive environment that fosters innovation and excellence, and we welcome talented professionals to join our mission to shape the future of clinical development.

Job Description:

We have an exciting opportunity for a Senior Clinical Data Management Director to join our Early Phase Data Management department. The successful candidate will oversee data management teams, studies, and programs under the general direction of the Senior Manager/Director of Data Management.

  • Provide planning estimates for project scope, schedule, and resource requirements
  • Ensure studies are properly managed and delivered

The role will collaborate with Clinical Operations, Biostatistics, SAS Programming, Medical Writing, and Quality Assurance to ensure data collected during trials meets corporate standards and regulatory guidelines for data integrity.

Role Overview:

The Early Phase service line specializes in the strategic development, management, and analysis of studies and programs that support Phase 1/2a clinical development.

Responsibilities:

The Senior Clinical Data Management Director will 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 other study-related documents
  • Maintain, clean, and lock EDC study databases

Additional responsibilities include reviewing project contracts, managing overall project budgets, negotiating with clients, and traveling approximately 15% domestically and/or internationally.

Requirements:

To be successful in this role, you will need:

  • 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
Estimated Salary:

$120,000 - $180,000 per annum, depending on experience.



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