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Study Operations Manager I - Remote

Posted 2 days ago
Project Management
Full Time
India

Overview

The Study Operations Manager I at Parexel is responsible for overseeing clinical study management, ensuring compliance with regulatory standards, and leading local study teams to drive effective study delivery.

In Short

  • Support Global Study Managers and local study teams.
  • Manage study start-up processes and site activations.
  • Oversee vendor management and ensure timely deliverables.
  • Ensure compliance with global and local regulations.
  • Communicate effectively with internal and external stakeholders.
  • Identify and mitigate risks in study execution.
  • Drive data cleaning and quality assurance processes.
  • Provide protocol-level guidance to study team members.
  • Lead operational effectiveness initiatives.
  • Support implementation of new clinical trial technologies.

Requirements

  • Bachelor’s or Master’s degree in a relevant field.
  • 5+ years of operational clinical trial experience.
  • Strong knowledge of Good Clinical Practice (GCP).
  • Experience in managing study management tasks.
  • Ability to work in a matrix management environment.
  • Excellent verbal and written communication skills.
  • Detail-oriented with strong analytical skills.
  • Ability to adapt to changing technologies and processes.
  • Willingness to travel as required.
  • Fluency in English is required.

Benefits

  • Opportunity to work in a global health-focused organization.
  • Engagement in innovative clinical trial methodologies.
  • Supportive work environment fostering professional growth.
  • Comprehensive training and development programs.
  • Competitive salary and benefits package.

P.I

Parexel International

Parexel International Limited is a leading global biopharmaceutical services organization headquartered near Boston, Massachusetts, and in Durham, North Carolina. With over 16,000 employees and a presence in more than 100 countries, Parexel specializes in comprehensive drug development capabilities, including regulatory expertise, Phase I-IV clinical research services, and advanced commercialization solutions. The company is dedicated to improving global health by providing innovative clinical development solutions, underpinned by a strong commitment to empathy and making a difference in patients' lives. Parexel's collaborative approach fosters partnerships across various disciplines, ensuring high-quality scientific contributions and the successful delivery of epidemiology services and real-world studies.

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