Clinical Project Lead, Oncology

• Lead end-to-end country-level trial management, from study start-up through database lock and closeout
• Serve as the primary contact for assigned clinical trials within your country
• Ensure delivery of high-quality, compliant data and documentation aligned with ICH-GCP, SOPs, and regulatory standards
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
• Partner with CRA's, Global Project Leads, and cross-functional teams to ensure successful study execution
• Lead site feasibility, selection, and activation processes
• Drive investigator engagement and site performance, including recruitment and retention strategies
• Monitor study progress through systems and reports; implement corrective and preventive actions (CAPA) when needed
• Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
• Oversee patient safety reporting (AEs/SAEs) within required timelines
• Manage country-level budgets, forecasting, and financial tracking
• Oversee local vendors and site payments, ensuring timely and accurate processing
• Coordinate ethics and regulatory submissions/approvals in collaboration with start-up teams
• Ensure compliance with local regulations and global standards (ICH-GCP)

• Bachelor's degree in life sciences, healthcare, or related field
• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
• Excellent communication and stakeholder management skills
• Proficiency in clinical systems (e.g., CTMS, eTMF)
• 3-5+ years of total trial management experience
• Experience managing complex or early-phase trials
• Demonstrated ability to lead cross-functional teams and drive performance

Demonstrates expertise in clinical trial management, ensuring compliance with ICH-GCP and regulatory standards while effectively leading cross-functional teams to achieve recruitment and performance targets.

• Clinical Trial Management
• ICH-GCP Compliance
• Stakeholder Management
• CTMS Proficiency
• Cross-Functional Team Leadership

• Trial Management
• Regulatory Requirements
• Data Documentation
• Site Feasibility
• Patient Safety Reporting
• Budget Management
• Financial Tracking
• Recruitment Strategy
• Corrective And Preventive Actions
• Study Execution

• Excellent Communication
• Stakeholder Management

• Clinical Research
• Life Sciences
• Healthcare
• Regulatory Standards
• Site Activation

• CTMS
• ETMF