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)

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

• Clinical Trial Management


• ICH-GCP Compliance


• Stakeholder Management


• CTMS Proficiency


• Cross-Functional Team Leadership

ATS Optimization Keywords

Hard Skills

• Trial Management


• Regulatory Requirements


• Data Documentation


• Site Feasibility


• Patient Safety Reporting


• Budget Management


• Financial Tracking


• Recruitment Strategy


• Corrective And Preventive Actions


• Study Execution

Soft Skills

• Excellent Communication


• Stakeholder Management

Industry Keywords

• Clinical Research


• Life Sciences


• Healthcare


• Regulatory Standards


• Site Activation

Tools & Technologies

• CTMS


• ETMF