Senior Research Operations Manager

16 hours ago

Bhavnagar, Gujarat, India beBeeResearch Full time ₹ 9,00,000 - ₹ 12,00,000

Job Overview:

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

About the Role:

  • Clinical Trial Leadership:

    1. Plan, initiate, and manage clinical research projects from start to finish, coordinating execution and overseeing adherence to protocols, timelines, and budgets.
    2. Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards, providing oversight on recruitment, enrollment, and monitoring of clinical trial subjects.
    3. Manage relationships with clinical research organizations (CROs), investigators, and external vendors, fostering effective collaboration and communication.

  • Team Management:

    1. Lead and mentor clinical research staff, ensuring they are trained and performing effectively, assigning tasks and responsibilities based on project needs.
    2. Develop training programs and provide ongoing professional development for research teams, promoting continuous improvement and best practices.

  • Regulatory Compliance & Quality Assurance:

    1. Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications, ensuring timely reporting of adverse events.
    2. Monitor compliance with federal, state, and local regulations, as well as company policies, maintaining a high standard of quality and integrity in clinical trial data collection and analysis.

  • Study Design & Protocol Development:

    1. Work with scientific and medical teams to develop clinical trial protocols, ensuring alignment with study objectives, regulatory standards, and ethical guidelines.
    2. Evaluate feasibility and risk of proposed studies, identifying areas for process improvement and implementing best practices to optimize research efficiency and compliance.

  • Data Management & Reporting:

    1. Ensure efficient and accurate data collection, monitoring, and analysis, reviewing and analyzing clinical trial data to ensure quality and integrity.
    2. Prepare and present progress reports to senior leadership and stakeholders, highlighting key findings and recommendations for future studies.

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