Clinical Research Operations Director

3 days ago

Nellore, Andhra Pradesh, India beBeeResearch Full time ₹ 18,00,000 - ₹ 25,20,000
Job Summary:

The Senior Clinical Research Manager is responsible for overseeing and managing clinical trials and research studies. This role ensures timely completion, compliance with regulatory standards, and effective collaboration across departments.

Key Responsibilities:

  • Clinical Trial Management: Plan, initiate, and manage projects from start to finish, coordinating execution and adherence to protocols, timelines, and budgets.
  • Ensure Good Clinical Practice (GCP), regulatory requirements, and ethical standards are met.
  • Manage relationships with external vendors and stakeholders.

Team Leadership:

  • Lead, mentor, and train clinical research staff, ensuring they perform effectively.
  • Assign tasks and develop training programs for ongoing professional development.

Regulatory Compliance:

  • Oversee preparation and submission of regulatory documentation, monitoring compliance and reporting adverse events.
  • Ensure studies meet ethical and regulatory standards.

Study Design & Protocol Development:

  • Work with scientific and medical teams to develop clinical trial protocols, evaluating feasibility and risk.

Data Management and Reporting:

  • Ensure efficient data collection, monitoring, and analysis, reviewing and analyzing data quality and integrity.
  • Prepare progress reports for senior leadership and stakeholders.

Budget and Resource Management:

  • Develop and manage project budgets, allocating resources efficiently.

Collaboration and Communication:

  • Foster communication between internal and external teams, resolving issues and providing solutions.

Continuous Improvement:

  • Identify areas for process improvement, implementing 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: 8-18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
  • Skills: Strong project management, leadership, organizational, communication, and problem-solving skills.
  • Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

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