Clinical Operations Manager responsible for overseeing protocol performance and compliance across assigned clinical trials in India. The role manages country and site budgets, executes regulatory submissions, coordinates with internal and external stakeholders, and ensures adherence to ICH/GCP standards and local regulations.
Responsibilities
Manage country and site budgets, develop clinical trial research agreements, and oversee payment reconciliation
Execute clinical trial country submissions and approvals, interact with IRB/IEC and regulatory authorities
Develop local language materials including informed consents and coordinate translations
Oversee clinical supplies management, filing, archiving, and ensure local regulatory and financial compliance
Coordinate with internal teams and external vendors to deliver country-specific trial commitments and milestones
Requirements
5 years clinical research experience or combined clinical research and finance/business experience
Bachelor's degree in business, finance, administration, life science, or healthcare-related field
Expertise in clinical systems, tools, metrics, and local regulatory environment
Strong budget and contract negotiation skills with understanding of submission and approval processes
Fluency in local language and English, both written and verbal
Ability to work independently with minimal oversight and influence stakeholders indirectly
Clinical Operations Manager Brief Description of Position This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, internal policies and procedures, quality standards and adverse event reporting requirements internally and https://jobeax.com/link/9dMM7TL51BQQyJce ...
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