Remote Otter LogoRemoteOtter

Senior Manager, Clinical Operations - Remote

Posted 6 days ago
All others
Full Time
Brazil

Overview

The Senior Manager of Clinical Operations will lead cross-functional teams to support R&D strategies, ensuring the successful execution of clinical studies and compliance with regulatory standards.

In Short

  • Partner with stakeholders to support R&D strategy.
  • Lead the GSO-SM team in local strategy and operational plans.
  • Accountable for feasibility activities and site selection.
  • Oversee execution of clinical studies and data collection.
  • Communicate effectively with cross-functional teams.
  • Monitor study progress and drive local action plans.
  • Identify risks and develop mitigation strategies.
  • Ensure compliance with ICH-GCP and local regulations.
  • Manage local staff and resources within budget.
  • Engage with external industry stakeholders.

Requirements

  • Doctorate degree with 4 years of clinical experience, or Master’s with 8 years, or Bachelor’s with 10 years.
  • 4 years of managerial experience.
  • Experience in biopharmaceutical clinical research.
  • Knowledge of clinical trial management regulations.
  • Fluency in English.
  • Experience with clinical trial management systems.
  • Strong project and program management skills.
  • Extensive knowledge of ICH/GCP guidelines.
  • Ability to engage local cross-functional teams.
  • Various therapeutic area knowledge.

Benefits

  • Opportunity to work in a leading biotechnology company.
  • Commitment to diversity and inclusion in the workplace.
  • Engagement in innovative human therapeutics development.
  • Support for professional growth and development.
  • Collaborative work environment.
Amgen logo

Amgen

1074 Amgen Technology Pvt Ltd. is a leading biotechnology company dedicated to improving the quality of life for patients suffering from serious illnesses. Since its inception in 1980, Amgen has pioneered advancements in biotech, focusing on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. The company is committed to discovering, developing, manufacturing, and delivering innovative human therapeutics, leveraging advanced human genetics to address complex diseases. With a collaborative and science-based culture, Amgen strives to make a lasting impact on patients' lives while fostering an inclusive environment for its diverse workforce. As a global leader in biotechnology, Amgen continues to develop a pipeline of medicines aimed at addressing high unmet medical needs and improving health outcomes worldwide.

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