
Oncology Clinical Research Manager
24 hours ago
Onsite Oncology Clinical Trial Lead
Our organization is seeking a highly skilled onsite oncology clinical trial lead to oversee the execution of Phase I, II and III studies at national institutions in India. This role will play a pivotal part in driving site activation, regulatory compliance, and clinical delivery in line with global sponsor expectations.
Key Responsibilities:
- Manage onsite operations and engagement for assigned phase's studies in India
- Build and maintain strong relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals
- Oversee timely and compliant Patient Screening Site Visits (PSSVs), site initiation visits (SIVs), 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 assessments and drive mitigation strategies across sites
- Provide oversight to field CRAs and monitor site compliance
- Contribute to internal SOP development and quality initiatives
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 onsite 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
Benefits:
Working on cutting-edge oncology clinical trials, developing expertise in cancer treatment research, and contributing to improving patient outcomes.
Others:
This is an excellent opportunity for those passionate about cancer research to join our team and make a meaningful impact in the healthcare industry.
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