Clinical Trial Manager, FSP
Contribute to Effective Management of FSP Project for Major Global Pharma Client
Responsible for Final Clinical Deliverable for Major Oncology Studies
- Global CRO with specialised FSP (Functional Service Provider) unit
Ensure that clinical strategies are translated into operational plans and executed in line with clinical development plans.
Align operational execution activities with agreed upon project priorities, timings and quality specifications and adhere to all relevant regulations including GCP, ICH and PhRMA guidelines, Regulatory requirements, and client's SOPs and policies.
- Ensure consistency and best practices are followed on all processes, protocols, and within the Clinical Trial Management System (CTMS)
- Take a lead role in managing projects and collaborating with departments within client's organization such as drug supply, regulatory, data management, biostatistics, medical writing and drug safety
- Ensure proper training is implemented to demonstrate to demonstrate CFR, GCP/ICH compliance
Responsible for quality control plan for the clinical trials site monitoring and management, both for the external field staff and within the internal CTM staff
Science Degree with significant pharmaceutical industry or clinical development/medicine experience
Experience of site monitoring and study management responsibility is required
Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based)
Knowledge of concepts of clinical research and drug development
General therapeutic area education and training
- Opportunity to work closely with major top 10 global pharmaceutical company on assigned oncology studies