Senior Medical Operations Lead

4 days ago


Hyderabad Secunderabad Telangana, India beBeeClinical Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title: Assistant General Manager

Key Responsibilities:

  • Lead and oversee medical monitoring of in-house clinical trials, ensuring compliance with regulatory requirements.
  • Collaborate with CROs to monitor outsourced projects and provide expert guidance on clinical documents.
  • Organize and facilitate Subject Expert Committee meetings for clinical trials and marketing approvals, providing critical input on project developments.

Secondary Responsibilities:

  • Review and analyze ICSRs, aggregate reports, signal reports, and risk management plans to identify areas for improvement.
  • Develop and review clinical and non-clinical overviews and summaries of CTDs, ensuring accuracy and compliance with regulations.
  • Provide expertise on medical rationale for CT waiver applications, working closely with cross-functional teams.
  • Evaluate new products for development, considering market trends, competitor analysis, and regulatory requirements.
  • Design and develop training programs for team members, focusing on comparative safety and efficacy, product evaluations, and marketing requests.
  • Mentor and train team members to acquire required skills, enabling timely deliverables and supporting career growth.

Requirements:

  • Proven experience in medical monitoring, clinical research, and regulatory affairs.
  • Excellent communication and leadership skills, with the ability to work effectively in a fast-paced environment.
  • Strong analytical and problem-solving skills, with a keen eye for detail.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.


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