Clinical Operations & Trial Management
- Manage over 20 clinical trial sites for a Site Management Organization (SMO).
- Plan, implement, and monitor clinical studies, ensuring adherence to budget, timelines, and quality standards.
- Ensure 100% patient recruitment and retention according to GCP guidelines.
- Coordinate with hospital management, physicians, sponsors, regulatory agencies, and patients.
- Conduct staff training, periodic site team meetings, and review meetings.
- Optimize resources and costs to improve profitability and efficiency.
- Drive diversification of services offered by the SMO.
Quality, Compliance & Regulatory Affairs
- Ensure compliance and quality across all clinical trial sites, bioanalytical labs, pharmacokinetics/biostatistics, medical writing, and computer system validations.
- Conduct protocol reviews, site qualification audits, site initiation, monitoring report reviews, and TMF assessments.
- Maintain documentation to meet internal and regulatory standards.
- Host and manage regulatory inspections from authorities like USFDA, WHO, UK-MHRA, ANVISA, and sponsors.
- Develop and oversee auditing programs covering all phases of clinical studies.
