Senior Director of Clinical Operations

1 week ago

Surat, Gujarat, India beBeeClinicalResearch Full time ₹ 30,00,000 - ₹ 60,00,000
Job Summary

The Senior Clinical Research Manager will oversee the strategic direction and operational delivery of clinical trials and research studies, ensuring they are completed on time, within regulatory standards, and in compliance with Good Clinical Practice (GCP).

  • Develop and implement clinical research strategies to achieve project goals and objectives.
  • Coordinate and manage the execution of clinical trials, including protocol development, site selection, and data management.
  • Ensure compliance with regulatory requirements, ethical standards, and company policies.
  • Provide oversight on the recruitment, enrolment, and monitoring of clinical trial subjects.

Key Responsibilities

  • Lead and mentor clinical research staff, providing training and coaching to ensure effective performance.
  • Assign tasks and responsibilities to team members based on project needs and expertise.
  • Develop and maintain relationships with clinical research organizations (CROs), investigators, and external vendors.
  • Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.

Qualifications

  • Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
  • At least 8 to 18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
  • In-depth knowledge of clinical trial management, regulatory requirements, and GCP principles.

Skills

  • Strong project management, leadership, and organizational skills.
  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
  • Proficiency in clinical research software and data management systems.

Certifications

  • Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification is an asset.

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