- 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