Senior Clinical Research Lead

3 days ago

Meerut, Uttar Pradesh, India beBeeClinical Full time ₹ 30,00,000 - ₹ 50,00,000

Job Overview:

This Clinical Trials Manager role is a critical position in our company, responsible for leading clinical operations and site-level engagement for assigned Phase's studies in India.

The successful candidate will have a strong working knowledge of GCP, ICH, and CDSCO guidelines, as well as experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers.

  • 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.

Required Skills and 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.

Company Information:

Our company 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.

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