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367 Sandoz Jobs

Clinical Operations Manager (d/f/m)

5-8 years

Hyderabad / Secunderabad

1 vacancy

Clinical Operations Manager (d/f/m)

Sandoz

posted 2d ago

Job Role Insights

Flexible timing

Job Description

As a Clinical Operations Manager you will be responsible for the planning, execution and delivery of assigned clinical operational activities in conduct of clinical trial(s) and ensuring all deliverables are met within defined timelines and maintaining high quality and compliance with Sandoz processes, ICH/GCP and applicable regulatory requirements.
Your key responsibilities:
Your responsibilities include, but not limited to:
  • Execute assigned operational activities in conduct of clinical trial(s) in close collaboration with Clinical Operations Associate Director.
  • Collaborate with External Service Providers to ensure timely delivery of outsourced tasks.
  • Contribute to and/or provide oversight on the content of key trial documents e.g. clinical trial protocol, informed consent, trial-specific operating manuals, project plans, safety management plan etc.
  • Coordinate the development, maintenance, and execution of the cross-functional Sponsor Oversight Plan.
  • Plan and coordinate clinical trial quality risk management activities.
  • Oversee outsourced monitoring activities including performing sponsor oversight visits at sites to proactively identify issues on a study and site, as well as ensuring resolution of identified issues.
  • Perform quality control and oversight in own area of responsibilities. Coordinate and track quality control activities.
  • Ensure timely identification, management and documentation of quality issues/deviations in conjunction with Clinical Quality Assurance.
What you will bring to the role:
  • Bachelor s Degree or equivalent qualification in life science/healthcare.
  • Minimum 5 years of experience in clinical development or associated fields. Experience in clinical operations is preferred.
  • Solid knowledge of Good Clinical Practice and worldwide regulatory requirements related to assigned area.
  • Fluent English (oral and written).

Employment Type: Full Time, Permanent

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