
Oncology Clinical Research Manager
1 day ago
Job Opportunity: Oncology Clinical Research Manager
We are seeking a seasoned oncology clinical research manager to lead the execution of phase I, II, and III 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.
- Manage clinical operations and site-level engagement for assigned phase studies in India
- Develop and maintain 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 and local EC timelines
- Conduct ongoing risk assessment and drive mitigation strategies across sites
- Provide oversight to field CRAs and monitor site compliance
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
Responsibilities:
• Develop and implement clinical trial plans and strategies
• Collaborate with cross-functional teams to ensure smooth trial execution
• Conduct regular site assessments and audits
• Provide training and support to field CRAs
• Analyze and report on trial performance metrics
Requirements:
- 5+ years of clinical research experience in a management or leadership role
- Proven track record of successfully leading multiple clinical trials simultaneously
- Excellent project management and organizational skills
- Strong analytical and problem-solving skills
- Ability to work in a fast-paced environment and prioritize tasks effectively
Preferred Qualifications:
- Master's degree in a relevant field
- Certification in clinical research or a related field
- Experience with clinical trial management software and electronic data capture systems
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