Job Opening For the post of Associate Director

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Position Overview:

The Associate Director of Clinical Operations is responsible for leading and managing clinical trials, ensuring that they are conducted efficiently, ethically, and in compliance with regulatory requirements. This role involves overseeing the planning, execution, and close-out of clinical trials, as well as managing a team of clinical operations professionals. The Associate Director will work closely with sponsors, internal teams, and external vendors to ensure successful trial outcomes.

Key Responsibilities:

• Leadership and Management:
  
• Lead and mentor a team of Clinical Operations Managers, Clinical Research Associates (CRAs), and other staff.
• Develop and implement strategies to enhance team performance and ensure high-quality trial execution.
• Oversee staffing and resource allocation to ensure that clinical trials are adequately supported.
• Clinical Trial Oversight:
  
• Manage the planning, initiation, execution, and close-out of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
• Ensure the implementation of standard operating procedures (SOPs) and best practices across all trials.
• Monitor trial progress, identify and resolve issues, and ensure that trials are conducted in compliance with Good Clinical Practice (GCP) and other relevant regulations.
• Sponsor and Stakeholder Interaction:
  
• Serve as the primary point of contact for sponsors and other key stakeholders.
• Provide regular updates on trial progress, including site performance, data quality, and adherence to timelines and budgets.
• Address sponsor queries and concerns in a timely and professional manner.
• Regulatory and Compliance:
  
• Ensure that clinical trials are conducted in compliance with local and international regulatory requirements.
• Oversee the preparation and submission of regulatory documents and ensure timely responses to regulatory agencies.
• Conduct site visits and audits to ensure compliance with GCP and study protocols.
• Budget and Resource Management:
  
• Develop and manage budgets for clinical trials, ensuring cost-effective use of resources.
• Monitor expenditures and financial performance, making adjustments as necessary to stay within budget.
• Risk Management:
  
• Identify and mitigate risks associated with clinical trials, including potential delays, compliance issues, and data quality concerns.
• Implement risk management strategies and contingency plans to address potential challenges.
• Process Improvement:
  
• Identify opportunities for process improvements and implement changes to enhance operational efficiency and trial outcomes.
• Stay informed about industry trends, regulatory changes, and emerging technologies to drive innovation within the clinical operations team.
• Training and Development:
  
• Provide training and development opportunities for team members to enhance their skills and knowledge.
• Ensure that all staff are up-to-date with training requirements and regulatory changes.