Clinical Research Leader

23 hours ago

Ghaziabad, Uttar Pradesh, India beBeeOncology Full time ₹ 1,20,00,000 - ₹ 1,50,00,000
Clinical Research Leader

We are seeking an experienced Clinical Trial Manager 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.

  • Lead clinical operations and site-level engagement for assigned Phase's studies in India
  • Manage relationships with Principal Investigators, 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 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
Job Requirements
  • Phase I, II and III Oncology Studies
  • Site Activation, Regulatory Compliance, and Clinical Delivery
  • Multisite Study Management and Remote Monitoring Teams
  • Regulatory Submissions and Ethics Committee Approvals
  • Risk Assessment and Mitigation Strategies
Required Skills
  • Life Sciences Degree
  • Clinical Research Experience
  • Oncology or Immunotherapy Trials
  • GCP, ICH, and CDSCO Guidelines
  • CTMS, EDC, and eTMF Systems
Benefits

This role offers opportunities for professional growth, collaboration with expert teams, and contributions to groundbreaking research. Apply now to take your career to the next level

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