Senior Clinical Operations Manager

2 days ago

Alleppey, Kerala, India beBeeClinicalResearch Full time ₹ 18,00,000 - ₹ 25,00,000
Job Summary

The Senior Clinical Research Manager leads and coordinates clinical trials, ensuring timely completion, regulatory compliance, and quality of research data.

Key Responsibilities:
  1. Clinical Trial Oversight
  • Plan, initiate, and manage clinical research projects from start to finish, ensuring adherence to protocols, timelines, and budgets.
  • Coordinate the execution of clinical trials, monitoring for compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
  • Oversee recruitment, enrollment, and monitoring of clinical trial subjects, ensuring accurate data collection and analysis.
  • Manage relationships with external vendors, investigators, and stakeholders, fostering effective collaboration and communication.
Team Leadership and Development
  • Lead, mentor, and train clinical research staff, ensuring they possess the necessary skills and knowledge to perform effectively.
  • Assign tasks and responsibilities to team members based on project needs, promoting a culture of accountability and teamwork.
  • Develop and implement training programs, providing ongoing professional development opportunities for research teams.
Regulatory Compliance and Risk Management
  • 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, identifying areas for improvement and implementing corrective actions.
  • Evaluate risks associated with clinical trials, developing strategies to mitigate potential issues and ensure study integrity.
Study Design and Protocol Development
  • Collaborate with scientific and medical teams to develop clinical trial protocols, ensuring alignment with study objectives, regulatory standards, and ethical guidelines.
  • Evaluate the feasibility and risk of proposed studies, making informed decisions about resource allocation and budgeting.
Data Management and Reporting
  • Ensure efficient and accurate data collection, monitoring, and analysis, leveraging technology and best practices to optimize research outcomes.
  • Review and analyze clinical trial data, identifying trends, patterns, and areas for improvement.
  • 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 meet clinical trial goals and objectives.
  • Oversee resource allocation, including personnel, equipment, and materials, ensuring that research initiatives are executed efficiently and within budget.
Communication and Collaboration
  • Foster open communication among internal teams, external partners, and key stakeholders, promoting a culture of transparency and trust.
  • Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution and coordination.
  • Resolve issues related to clinical trial execution, applying creative problem-solving skills and expertise to find solutions.
Continuous Improvement and Quality Assurance
  • Identify areas for process improvement in clinical trial execution and management, developing strategies to enhance research efficiency and compliance.
  • Implement best practices and lessons learned, ensuring that research initiatives are executed with quality, integrity, and excellence.

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