Lead Oncology Studies Professional

2 days ago

Kollam, Kerala, India beBeeClinicalTrialManager Full time ₹ 15,00,000 - ₹ 20,00,000

Clinical Trial Manager Job Opportunity

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We are seeking an experienced Clinical Trials professional 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.

This position requires a seasoned manager with expertise in leading clinical operations and site-level engagement for assigned Phase's studies in India. The ideal candidate will have experience managing relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals.

The successful candidate will oversee timely and compliant Patient Screening, Site Initiation Visits (SIV), patient recruitment, and data collection. Additionally, they will ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets.

Candidates should be proficient in collaborating with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness. They will also coordinate regulatory submissions and ethics committee (EC) approvals; ensuring alignment with CDSCO, ICMR, and local EC timelines.

Ongoing risk assessment and mitigation strategies across sites will be a critical component of this role. Furthermore, the selected candidate will provide oversight to field CRAs and monitor site compliance. Contribute to internal SOP development and quality initiatives.

  • 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.

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