Oncology Study Leader

2 days ago

Bengaluru, Karnataka, India beBeeClinical Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Clinical Trial Manager

At the forefront of oncology research, we seek an accomplished Clinical Trial Manager to spearhead the execution of pivotal Phase I, II, and III studies at esteemed national institutions in India.

This strategic role drives site activation, regulatory compliance, and clinical delivery in harmony with global sponsor expectations.

  • Lead clinical operations and site-level engagement for assigned Phases' studies in India
  • Establish and maintain robust relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals
  • Oversee timely and compliant Patient Screening and Site Validation (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:
  • Bachelor's 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

This position offers an exciting opportunity to contribute to groundbreaking cancer research while honing your expertise in clinical trial management. If you possess a strong passion for oncology and exceptional leadership skills, we encourage you to apply for this rewarding role.

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