Central Monitor (US)

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Full Remote
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Offer summary

Qualifications:

Minimum of 3 years' experience in clinical trials with knowledge of study phases and regulatory guidance (e.g., ICH GCP)., Strong experience in clinical operations, Risk-Based Quality Management (RBQM), and data management., Aptitude for data analytics and critical thinking to identify risks and make data-driven decisions., Bachelor’s degree or higher in a scientific or business-related discipline or equivalent experience..

Key responsabilities:

  • Guide study teams in identifying critical data and conducting Risk Assessments to enhance study success.
  • Coach customers on implementing platform methodologies and optimizing monitoring resources for study-specific risks.
  • Assess risks and provide actionable insights to customer study teams, investigating atypical data patterns.
  • Document lessons learned and collaborate with the Product team to ensure system updates meet customer needs.

CluePoints logo
CluePoints SME https://cluepoints.com/
201 - 500 Employees
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Job description

Job Description

Are you ready to make a real impact on the future of clinical trials and patient safety? As a Central Monitor, you will play a pivotal role in transforming clinical research through our industry-leading platform and product suite. If you're passionate about leveraging data, optimizing monitoring strategies, and ensuring clinical studies run at their highest potential, we want you to be part of our team! 


About Us:
At CluePoints, we’re pioneers in Risk-Based Quality Management (RBQM), and our solutions are revolutionizing the way clinical trials are managed. With a strong commitment to patient safety, data quality, and operational excellence, we empower study teams and customers to achieve their goals faster, smarter, and more efficiently. As a Central Monitor, you’ll be a key player in shaping the future of clinical trial monitoring and ensuring our solutions deliver maximum value to our customers. 

Job Requirements

What We’re Looking For: 

  • Experience: Minimum of 3 years' experience working in clinical trials with a solid understanding of study phases, design, execution, and regulatory guidance (e.g., ICH GCP).
  • Knowledge: Strong experience in clinical operations, RBQM or Central Monitoring, including data management and medical data review. Familiarity with clinical trials across multiple therapeutic areas is a plus.
  • Skills: Data analytics aptitude and critical thinking skills to identify risks and drive decisions based on data.
  • Education: Bachelor’s degree or higher in a scientific or business-related discipline (or equivalent experience).


Ready to Make a Difference?
Join us at the forefront of clinical trial monitoring. If you’re passionate about using data to drive clinical trial success and make a lasting impact, we’d love to hear from you! 


Apply now to be part of our innovative and dynamic team, shaping the future of clinical trials! 

Job Responsibilities

What You’ll Do: 

  • Enable Successful Platform Implementation: Guide study teams and data analysts in identifying critical data, conducting comprehensive Risk Assessments, and determining Key Risk Indicators (KRIs) and Quality Tolerability Limits (QTLs) that enhance study success.
  • Provide Expert Coaching & Guidance: Coach customers on implementing our platform and products methodologies, helping them optimize monitoring resources to address study-specific risks. Mentor data analysts to define KRIs based on risk assessments, protocols, and study documentation.
  • Signal Management & Communication: Assess and address risks, providing actionable insights to customer study teams. Investigate atypical data patterns, define follow-up actions, and communicate your findings to guide decision-making and improve operational efficiency.
  • Drive Continuous Improvement: Document and share lessons learned to foster cross-study knowledge sharing. Collaborate with the Product team to test and validate system updates, ensuring that new features meet the needs of our customers.
Job Benefits

Why Join Us? 

  • Impactful Work: Help shape the future of clinical trial monitoring, improving patient safety and data quality while contributing to succesful study delivery.
  • Collaborative Environment: Work with a team of experts passionate about advancing clinical trials through innovative data-driven solutions.
  • Continuous Growth: Support your personal and professional development as you continue to grow expertise in risk-based approaches, data analytics and clinical trial operations.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Critical Thinking
  • Teamwork
  • Communication
  • Problem Solving

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