Added
4 days ago
Type
Full time
Salary
Salary not provided

Related skills

regulatory submissions etmf ctms ip capa

πŸ“‹ Description

  • Lead planning and oversight of clinical studies per protocol and ICH-GCP.
  • Serve as primary client contact and ensure regulatory compliance.
  • Develop study documents: plans, ICF templates, CRF guidelines.
  • Manage site feasibility, enrollment targets, and recruitment strategy.
  • Oversee monitoring, IP management, and vendor coordination.
  • Manage CTMS metrics, eTMF, and CAPA processes.

🎯 Requirements

  • Bachelor's in science/health; advanced degree preferred.
  • 5-8 yrs clinical research with monitoring; Oncology Ph I exp in Asia preferred.
  • Strong knowledge of ICH-GCP, SOPs, regulatory submissions.
  • Excellent communication and leadership; cross-functional teams.

🎁 Benefits

  • Equal Opportunity Employer.
  • Reasonable accommodation available upon request.
  • Privacy policy notice.
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