Clinical Research Director

2 days ago

Mumbai, Maharashtra, India beBeeResearch Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Senior Clinical Research Leader

This is a high-level leadership position responsible for the strategic direction and operational management of clinical trials and research studies. The role requires expertise in project management, team leadership, and regulatory compliance.

Key Responsibilities:

  • Clinical Trial Management
    • Plan, initiate, and manage clinical research projects from start to finish.
    • Coordinate and oversee the execution of clinical trials, ensuring adherence 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 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.
    • 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 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 other departments to ensure effective study execution.
    • Resolve any 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.

Qualifications:


• Bachelor's degree in Life Sciences or a related field (Master's or higher preferred).


• 8 to 18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.


• Strong project management, leadership, and organizational skills; excellent communication and interpersonal skills; proficiency in clinical research software and data management systems; strong problem-solving and decision-making abilities.


• Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred.

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