Clinical Trial Manager

Job Title : Clinical Trial Manager

Onsite - Hyderabad

Company Overview : We eteraflex connects a fast-growing global CRO specializing in oncology, rare diseases, and immunotherapies. Our mission is to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led research environments across India.

Position Summary : We are seeking an experienced Clinical Trial Manager (CTM) to lead the execution of Phase I, II and III oncology studies at key national institutions in India. This role is pivotal in driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations.

Key Responsibilities :

• Lead clinical operations and site-level engagement for assigned Phase’s studies in India
• Manage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals
• Oversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection
• Ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets
• Collaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness
• Coordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelines
• Conduct ongoing risk assessment and drive mitigation strategies across sites
• Provide oversight to field CRAs and monitor site compliance
• Contribute to internal SOP development and quality initiatives

Key Qualifications :