Clinical Trial Manager
3 weeks ago
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 Phases 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:
- Bachelors degree in life sciences or related field; advanced degree preferred
- Minimum 6-8 years of clinical research experience with at least 3 years in an independent CTM role
- Demonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers
- Strong working knowledge of GCP, ICH, and CDSCO guidelines
- Proven track record managing multi-site studies and remote monitoring teams
- Excellent interpersonal, communication, and problem-solving skills
- Proficiency in CTMS, EDC, and eTMF systems is a plus
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