Clinical Trial Operations Specialist

2 days ago

Remote, India beBeeClinicalResearch Full time ₹ 1,04,000 - ₹ 1,30,878
Job Description

As a Clinical Research Manager, you will be responsible for overseeing the execution and performance of assigned clinical trials in accordance with ICH/GCP and country regulations.

Your key responsibilities will include:

  • Performance: You will be accountable for ensuring compliance and quality in assigned protocols, working closely with local CO roles and forecasting resource needs.
  • Management: You will serve as the point of contact for assigned protocols, driving execution and performance to meet country commitments.
  • Quality Oversight: You will oversee CRAs and CTCs, ensuring training compliance and conducting quality control visits. Review monitoring reports and escalate issues as needed.
  • External Customer Facing: You will collaborate with vendors, investigators, and external partners, overseeing site validations, selection, and recruitment.
  • Internal Collaboration & Strategy: You will work with local Pharmacovigilance, Regulatory Affairs, and Global Medical Affairs to support strategy development consistent with corporate needs.
Required Skills and Qualifications
  • University/college degree in a life science field preferred, or certification in a related health profession (nursing, medical, laboratory technology).
  • Minimum of four years of relevant clinical research experience in pharmaceutical or CRO industries, or equivalent experience in a healthcare setting may be considered.
  • Thorough knowledge of ICH Guidelines and GCP, with an understanding of regulatory requirements in various countries.
  • Strong understanding of the drug development process.
  • Fluent in English, both written and verbal.

Working as a Clinical Research Manager offers the opportunity to apply your expertise in a dynamic and challenging environment.

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