Chief Clinical Operations Director

2 days ago

Allahabad, Uttar Pradesh, India beBeeClinical Full time ₹ 18,00,000 - ₹ 23,00,000
Senior Clinical Research Manager

Job Summary:

The Senior Clinical Research Manager oversees the execution of clinical trials, ensuring compliance with regulatory standards and timelines.

  • Clinical Trial Management
    • Plan, initiate, and manage clinical research projects from start to finish.
    • Coordinate the execution of clinical trials, adhering to protocols and budgets.
    • Ensure compliance with Good Clinical Practice (GCP) and ethical standards.
    • Oversee the recruitment, enrolment, and monitoring of clinical trial subjects.
    • Manage relationships with external vendors and stakeholders.
  • Team Leadership
    • Lead and mentor clinical research staff, ensuring they are trained and performing effectively.
    • Assign tasks and responsibilities to team members based on project needs.
    • Develop training programs and provide ongoing professional development for research teams.
  • Regulatory Compliance
    • Prepare and submit regulatory documentation, including Institutional Review Board (IRB) applications.
    • Monitor compliance with federal and local regulations, as well as company policies.
    • Ensure timely reporting of adverse events.
  • Study Design & Protocol Development
    • Work with scientific and medical teams to develop clinical trial protocols.
    • Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.
    • Evaluate feasibility and risk of proposed studies.
  • Data Management and Reporting
    • Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.
    • Review and analyze clinical trial data to ensure quality and integrity.
    • Prepare and present progress reports to senior leadership and stakeholders.
  • Budget and Resource Management
    • Develop and manage project budgets.
    • Oversee resource allocation, including personnel and equipment.
  • Collaboration and Communication
    • Foster communication between internal teams and external partners.
    • Collaborate with clinical research coordinators and other departments to ensure effective study execution.
    • Resolve issues related to clinical trial execution.
  • Continuous Improvement
    • Identify areas for process improvement in clinical trial execution and management.
    • Implement best practices to optimize research efficiency and compliance.

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