Senior Clinical Operations Director

11 hours ago

Coimbatore, Tamil Nadu, India beBeeClinicalResearch Full time ₹ 14,53,284 - ₹ 28,38,576
Job Overview

The Senior Clinical Research Manager leads and manages clinical trials and research studies to ensure timely completion, compliance with regulatory standards, and optimal resource utilization.

  • Key Responsibilities:
    • Plan, initiate, and manage clinical research projects from start to finish, ensuring adherence to protocols, timelines, and budgets.
    • Coordinate and oversee the execution of clinical trials, ensuring 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 investigators, external vendors, and other stakeholders.
    • 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.
    • 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.
    • Work with scientific and medical teams to develop clinical trial protocols.
    • Evaluate feasibility and risk of proposed studies.
    • 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.
    • Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.
    • Oversee resource allocation, including personnel, equipment, and materials.
    • 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.
    • Identify areas for process improvement in clinical trial execution and management.
    • Implement best practices to optimize research efficiency and compliance.

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