Senior Clinical Operations Leader

8 hours ago


Jaipur, Rajasthan, India beBeeResearch Full time ₹ 18,00,000 - ₹ 25,00,000
Senior Clinical Research Manager

The Senior Clinical Research Manager is responsible for leading and managing clinical trials and research studies, ensuring timely completion within regulatory standards.

Key Responsibilities:
  • Clinical Trial Management
    • Plan, initiate, and manage clinical research projects from start to finish.
    • Coordinate and oversee 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 recruitment, enrolment, 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 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 ensure the study meets ethical and regulatory standards.
  • 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 any 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.
    Qualifications:
    • Education:
      • Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
    • Experience:
      • 8 to 18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
      • In-depth knowledge of clinical trial management, regulatory requirements, and GCP.
    • Skills:
      • Strong project management, leadership, and organizational skills.
      • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
      • Proficiency in clinical research software and data management systems.
      • Strong problem-solving and decision-making abilities.
    • Certifications:
      • Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).


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