Director of Clinical Trials

1 day ago

Palakkad, Kerala, India beBeeClinical Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Clinical Research Manager Position

This position oversees and manages clinical trials and research studies, ensuring timely completion and compliance with regulatory standards.

Key Responsibilities:
  1. Clinical Trial Management:
  • Plan, initiate, and manage clinical research projects from start to finish.
  • Coordinate and oversee the 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 the recruitment, enrollment, 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 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.
  • 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 that 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.

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