Senior Oncology Study Lead

2 weeks ago


Nellore, Andhra Pradesh, India beBeeClinicalResearch Full time ₹ 12,50,000 - ₹ 17,50,000
Clinical Research Manager Position

This is an exciting opportunity for an experienced Clinical Research Manager to lead the execution of Phase I, II and III oncology studies at key national institutions in India.

The successful candidate will be responsible for leading clinical operations and site-level engagement for assigned Phase's studies in India. This includes managing relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals.

  • Lead clinical operations and site-level engagement for assigned Phase's studies in India
  • Manage relationships with 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

This role requires a strong understanding of clinical research principles, excellent communication skills, and the ability to work effectively in a fast-paced environment. The ideal candidate will have a Bachelor's degree in life sciences or a related field, advanced degree preferred, and 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.



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