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Clinical Trial Manager
·Israel
On-siteFull-timeProject ManagementPharmaceutical ManufacturingBiotechnology Research
Manage clinical trials, ensure quality and compliance, coordinate teams and sites, develop study tools, monitor timelines and budgets, and achieve deliverables within contract scope for oncology and cell therapy projects.
Responsibilities
- Manage clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
- Develop clinical tools such as monitoring plans and guidelines in conjunction with the Data Quality Plan.
- Ensure timely setup, organization, and quality of Trial Master File sections.
- Collaborate with the project manager and lead team meetings to maintain timelines and quality.
- Monitor clinical activity timelines and metrics, implement recovery actions, and manage CRF collection and query resolution.
- Communicate with study sites and coordinate ethics committee and regulatory submissions.
Requirements
- Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
- Previous experience providing knowledge, skills, and abilities comparable to 5+ years.
- Good leadership, planning, and organizational skills.
- Familiarity with clinical monitoring practices, ICH GCP, FDA guidelines.
- Effective English communication and financial acumen.