Senior Director of Clinical Research Operations

1 week ago

Hyderabad, Telangana, India beBeeClinicalResearch Full time ₹ 1,80,00,000 - ₹ 2,51,00,000
Job Overview

The Senior Clinical Research Manager will lead and manage clinical trials and research studies, ensuring timely completion within budget and compliance with regulatory standards.

  • Clinical Trial Management:
    • Develop and execute clinical research projects from start to finish, coordinating the execution of clinical trials and overseeing adherence to protocols, timelines, and budgets.
    • Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards, providing oversight on the recruitment, enrollment, and monitoring of clinical trial subjects.
    • Build and maintain relationships with clinical research organizations (CROs), investigators, and external vendors.
  • Team Leadership:
    • Lead and mentor a team of clinical research staff, ensuring they are trained and performing effectively, assigning tasks and responsibilities based on project needs.
    • Develop training programs and provide ongoing professional development for research teams, fostering collaboration and open communication.
  • Regulatory Compliance:
    • Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications, ensuring timely reporting of adverse events.
    • Monitor compliance with federal, state, and local regulations, as well as company policies, ensuring the study meets ethical and regulatory standards.
  • Study Design & Protocol Development:
    • Work with scientific and medical teams to develop clinical trial protocols, ensuring they meet study objectives, regulatory standards, and ethical guidelines.
    • Evaluate feasibility and risk of proposed studies, making informed decisions to drive business growth.
  • Data Management and Reporting:
    • Ensure data collection, monitoring, and analysis are conducted efficiently and accurately, reviewing and analyzing clinical trial data to ensure quality and integrity.
    • Prepare and present progress reports to senior leadership and stakeholders, highlighting key findings and recommendations.
  • Budget and Resource Management:
    • Develop and manage project budgets, allocating resources effectively to ensure timely completion within financial constraints.
    • Oversee resource allocation, including personnel, equipment, and materials, driving efficiency and productivity.
  • Collaboration and Communication:
    • Foster collaboration between internal teams, external partners, and key stakeholders, resolving any issues related to clinical trial execution and providing solutions.
    • Provide clear and concise communication, ensuring all parties are informed and aligned with project goals and objectives.
  • Continuous Improvement:
    • Identify areas for process improvement in clinical trial execution and management, implementing best practices to optimize research efficiency and compliance.
    • Stay up-to-date with industry trends and emerging technologies, applying new insights and knowledge to drive business innovation.

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