Clinical Operations Lead (Clinical Trial Manager)
New
IndiaFull-TimeLead
Salary not disclosed
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Job Details
- Experience
- 4–6 years with a bachelor's degree or 7–9 years with a college diploma
- Required Skills
- Microsoft OfficeStakeholder management
Requirements
- Bachelor's degree with 4–6 years of relevant experience or college diploma with 7–9 years of related experience.
- Background in Health Sciences, Life Sciences, Nursing, or a related field.
- Minimum 3 years of experience as a Clinical Research Associate (CRA).
- Strong knowledge of clinical trial management processes, monitoring activities, and EDC systems.
- Solid understanding of GCP principles, ICH guidelines, local regulations, and IRB/EC requirements.
- Proficiency with Microsoft Office tools and clinical documentation systems.
- Strong report writing skills and ability to critically review clinical research documents.
- Proven ability to mentor and support clinical teams in a deadline-driven environment.
- Strong problem-solving, stakeholder management, and organizational skills.
- SoCRA and/or ACRP certification is an advantage.
Responsibilities
- Oversee clinical trial execution at regional and global levels ensuring study deliverables, quality standards, and timelines.
- Provide operational oversight of assigned clinical research associates (CRAs) and investigator sites to ensure compliance with ICH-GCP guidelines.
- Monitor site performance, recruitment progress, data collection, and documentation completion.
- Conduct co-monitoring and assessment visits to support CRA performance and site management.
- Review monitoring visit reports, protocol deviations, and corrective actions.
- Support site feasibility, startup activities, enrollment strategies, and recruitment planning.
- Develop and deliver study-specific training materials and guidance for CRAs and investigator sites.
- Serve as the primary operational contact for regional CRAs, providing mentoring and escalation management.
- Collaborate with sponsors and internal teams to provide study status updates and ensure operational alignment.
- Support vendor management and project financial processes including site payments and expenses.
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