Clinical Research Project Manager

Job Title:

About the Role:

Key Responsibilities:

Clinical Trial Management

• Oversee the conduct of Phase I–IV oncology clinical trials, ensuring adherence to study protocols, timelines, and quality standards.
  
• Counsel patients for study participation and manage informed consent processes.
  
• Submit study documents and obtain approvals from Ethics Committees and regulatory bodies.
  
• Coordinate with sponsors and CROs for study start-up, monitoring, and close-out activities.
  
• Manage trial budgets, agreements, and financial tracking related to research activities.
  

Team & Quality Oversight

• Lead, train, and supervise clinical research coordinators and site staff.
  
• Monitor trial records, ensure data accuracy, and perform internal quality control checks.
  
• Report Serious Adverse Events (SAEs) to DCGI and Ethics Committees within required timelines.
  
• Prepare and maintain essential trial documentation for EC review, audits, and regulatory inspections.
  

Regulatory Compliance & Governance

• Ensure compliance with DCGI regulations, ICMR guidelines, and GCP standards.
  
• Liaise with auditors and sponsors during monitoring visits and inspections.
  

Cellular Therapy & Research Support

• Support advanced research programs including Gamma Delta T-cell and TCR therapy trials, overseeing patient selection, logistics, infusion, and post-procedure monitoring.
  
• Collaborate with clinical teams to ensure safety, protocol adherence, and quality outcomes.
  

Process Development & SOP Management

• Develop and implement Standard Operating Procedures (SOPs) for the Research Unit.
  
• Establish streamlined workflows, quality control systems, and process improvements for clinical and cellular therapy research.
  

Qualifications & Skills:

• Master’s / Bachelor’s degree in Life Sciences, Pharmacy, or related field (Postgraduate in Clinical Research preferred).
  
• 5–10 years of experience in clinical research, preferably in oncology.
  
• In-depth understanding of GCP, ICH, DCGI, and ethical research practices.
  
• Strong leadership, documentation, and project management skills.
  
• Excellent communication and coordination abilities with multidisciplinary teams and sponsors.