Senior Clinical Operations Director

2 days ago

Rajahmundry, Andhra Pradesh, India beBeeClinicalResearch Full time ₹ 15,00,000 - ₹ 25,00,000
Job Summary

The Senior Clinical Research Manager will oversee the planning, execution and management of clinical trials ensuring timely completion within budget and regulatory compliance. This leader will supervise research teams, collaborate with cross-functional departments and provide strategic direction for clinical research activities.

Key Responsibilities:
  • Clinical Trial Management:
    • Plan, initiate and manage clinical research projects from start to finish.
    • Coordinate and oversee the execution of clinical trials adhering to protocols, timelines and budgets.
    • Ensure compliance with Good Clinical Practice (GCP), regulatory requirements and ethical standards.
    • Provide oversight on the recruitment, enrollment and monitoring of clinical trial subjects.
    • Manage relationships with clinical research organizations (CROs), investigators and external vendors.
  • 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:
    • Oversee the preparation and submission of regulatory documentation including Institutional Review Board (IRB) applications and clinical trial applications.
    • Monitor compliance with federal, state and local regulations as well as company policies.
    • Ensure timely reporting of adverse events and maintain study integrity.
  • 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 ensuring clinical trials are completed within financial constraints.
    • Oversee resource allocation including personnel, equipment and materials.
  • Collaboration and Communication:
    • Foster communication between internal teams, external partners and key stakeholders.
    • Collaborate with clinical research coordinators, data managers and other departments to ensure effective study execution.
    • Resolve issues related to clinical trial execution and provide solutions.
  • 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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