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Clinical Study Operations Manager FSP - Single sponsor/homebased

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
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Offer summary

Qualifications:

Minimum of 2+ years of operational clinical trial management experience., Degree or higher, preferably in a science-related field., Comprehensive knowledge of Good Clinical Practice and clinical regulatory operations., Experience in managing country-level operational activities and study start-up..

Key responsabilities:

  • Oversee study-specific country-level activities from startup to close.
  • Utilize study and site dashboards and reporting tools for effective management.
  • Coordinate tasks as part of a larger study management team.
  • Ensure compliance with clinical trial methodology and quality management standards.

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Parexel XLarge http://www.parexel.com
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is currently hiring for a Study Operations Manager, home-based.

Permanent, full-time.

Single sponsor dedicated to a worldwide biopharmaceutical company that relentlessly seeks breakthroughs to improve patients’ lives. Their daily innovation contributes to a healthier global community. This is where today’s visionaries, solution-seekers, and trailblazers converge to shape tomorrow’s groundbreaking solutions. Together, we have the power to revolutionize patients’ well-being. Every choice we make and every step we take is guided by our unwavering focus on patients, fostering an environment where innovation thrives.

The Study Operations Manager I (SOM I) have responsibilities for study specific country-level activities from study startup through conduct and study close on studies of limited complexity.

Candidates with the following experience will be considered:

  • A minimum of 2 + years of relevant operational clinical trial management experience is required.

  • Expertise in the use of study and site dashboards and reporting tools.

  • Experience in study start-up.

  • Comprehensive knowledge of own discipline with good knowledge of other disciplines ensures that the study can meet its goals and to serve as a resource for others.

  • Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team.

  • Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility

  • Demonstrated clinical research experience and/or study management/startup project manager experience.

  • Demonstrated experience in managing country-level operational activities and/or vendors.

  • Experience in study and quality management.

  • Knowledge of clinical trial methodology

  • Experience working in a matrix management environment.

  • Relevant operational clinical trial experience

  • Education: degree or higher - preferably science-related.

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Apply today!

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Experience

Spoken language(s):
English
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Other Skills

  • Team Management
  • Communication
  • Problem Solving

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