Senior Clinical Research Operations Director

1 day ago


Gandhinagar, Gujarat, India beBeeClinicalresearchprojectmanagement Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

Job Title: Clinical Research Project Lead

We are seeking an accomplished Clinical Research Project Lead to oversee clinical trials and research studies from initiation to completion. As a seasoned professional, you will lead cross-functional teams, collaborate with internal departments, and provide strategic direction for clinical research initiatives.

Key Responsibilities:

  • Plan, initiate, and manage clinical research projects ensuring timely completion within regulatory standards.
  • 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.
  • 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.
  • Evaluate feasibility and risk of proposed studies.
  • Prepare and present progress reports to senior leadership and stakeholders.

Requirements:

  • Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
  • 8-18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
  • 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.

Keyword: ClinicalResearchProjectManagement



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