Added
21 days ago
Type
Full time
Salary
Salary not provided

Related skills

gcp edc ich ctms budget

๐Ÿ“‹ Description

  • Lead the Site Start-up (SSU) department and shape strategy, processes, and systems for SSU
  • Collaborate with teams to ensure SSU delivery and client satisfaction (IRB/EC submissions, CA
  • Partner with Head of Site Start Up to evolve the SSU framework, tools, risk evaluations, and
  • Ensure trials comply with regulatory requirements, ICH/GCP, and SOPs across regions.
  • Drive SDU program leadership, escalation management, and continuous process improvement.
  • Support external and internal stakeholder meetings to promote PfM service excellence.

๐ŸŽฏ Requirements

  • Bachelors in life sciences or equivalent; 12+ years in clinical research with extensive SSU
  • Experience in CRO environments; people management experience.
  • Expert knowledge of GCP/ICH and clinical development; strong leadership track record.
  • Proven ability to manage complex SSU programs, budgeting, and cross-functional collaboration.
  • Proficient with MS Office and clinical software (CTMS, eTMF, EDC).
  • Excellent communication, organization, and change management skills; fluent in English.

๐ŸŽ Benefits

  • Global, remote-friendly role with representation in Europe.
  • Opportunity to influence SSU strategy and drive growth across PfM.
  • Collaborative environment with focus on quality, people, and performance.
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