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Clinical Trial Risk Based Monitoring Jobs in Michigan

$19.50 - $26.50/hr

Prepare and record sponsor invoices based on study milestones, participant visits, and other invoiceable activities in accordance with study budgets. * Review clinical trial contracts and budgets to ...

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Clinical Trial Risk Based Monitoring information

What is clinical trial risk based monitoring?

Clinical Trial Risk Based Monitoring (RBM) is a strategy used in clinical research to prioritize and focus monitoring activities on the most critical risks to patient safety and data integrity. Instead of monitoring every data point equally, RBM uses data analytics and risk assessment tools to identify which sites, processes, or data require more attention. This approach increases efficiency, reduces costs, and helps ensure that potential issues are detected and addressed promptly. RBM is supported by regulatory agencies and is increasingly adopted in both large and small clinical trials.

How does a clinical trial risk based monitoring professional typically collaborate with cross-functional teams during a study?

In a Clinical Trial Risk Based Monitoring role, you will regularly work with clinical research associates, data managers, statisticians, and regulatory teams to identify and address potential risks throughout a study. Collaboration often involves participating in meetings to review data trends, sharing insights about site performance, and helping to develop mitigation strategies. Effective communication is crucial, as you will be responsible for ensuring that all stakeholders are informed of key risks and recommended actions. This collaborative environment helps drive patient safety, data integrity, and overall trial success.

What are the key skills and qualifications needed to thrive in clinical trial risk based monitoring, and why are they important?

To thrive in Clinical Trial Risk Based Monitoring, you need expertise in clinical research, regulatory compliance, and data analysis, usually supported by a degree in life sciences or related fields. Familiarity with risk assessment tools, EDC (Electronic Data Capture) systems, and GCP (Good Clinical Practice) certification is typically required. Strong attention to detail, critical thinking, and effective communication help professionals proactively identify and address potential risks in trials. These skills are crucial for maintaining data integrity, ensuring patient safety, and optimizing the efficiency and quality of clinical studies.

What is the difference between Clinical Trial Risk Based Monitoring vs Clinical Trial Data Manager?

AspectClinical Trial Risk Based MonitoringClinical Trial Data Manager
Primary FocusMonitoring trial sites for risks and complianceManaging and ensuring accuracy of trial data
Required SkillsMonitoring protocols, regulatory knowledge, site managementData management, database systems, quality control
Work EnvironmentClinical sites, monitoring visits, remote oversightData centers, clinical trial databases, office setting
CertificationsGCP, monitoring certificationsCDMP, data management certifications

While both roles are integral to clinical trials, Risk Based Monitoring focuses on overseeing site performance and compliance to mitigate risks, whereas Data Managers concentrate on managing and validating trial data for accuracy and integrity.

What are popular job titles related to Clinical Trial Risk Based Monitoring jobs in Michigan?

For Clinical Trial Risk Based Monitoring jobs in Michigan, the most frequently searched job titles are:

What cities in Michigan are hiring for Clinical Trial Risk Based Monitoring jobs?

Cities in Michigan with the most Clinical Trial Risk Based Monitoring job openings:

Senior Manager, Clinical Scientist, Hematology

Warren, MI • On-site

$150 - $200/hr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 2 days ago

New


Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clinical Scientist to join our Clinical Sciences team, supporting rare hematologic conditions and/or immunologic diseases. In this role, you will lead the design, execution, and interpretation of clinical studies within a cross‑functional matrix environment while collaborating closely with Medical Directors, Clinical Study Teams, and Global Clinical SubTeams to advance early‑and late‑stage development programs. This position will support rare hematologic conditions and/or immunologic diseases.

This position offers the opportunity to contribute to a fast‑growing, science‑driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Tarrytown, NY or Warren, NJ

Work model/flexibility: Primarily on‑site with hybrid flexibility

Discover your role:
  • Lead clinical study design, execution, and data interpretation across a full development program
  • Partner with Medical Directors and cross‑functional teams to shape study strategy and scientific direction
  • Author and review key clinical documents, including protocols, amendments, and clinical study reports
  • Drive medical and safety data review to protect patient safety throughout the trial lifecycle
  • Apply deep therapeutic area knowledge to inform study design and risk mitigation
  • Represent Clinical Sciences in scientific advisory boards, steering committees, and safety monitoring meetings
  • Mentor and guide junior team members as part of a growing Clinical Sciences function
  • Ensure compliance with FDA, EMEA, ICH, and GCP standards across all study activities
This role might be for you:
  • Bachelor's degree required; advanced degree (PhD/MD/PharmD/MSc) in life sciences or healthcare preferred
  • 8+ years of pharmaceutical clinical drug development experience
  • Experience in rare hematologic conditions and/or immunologic diseases preferred
  • Demonstrated knowledge of GCP, clinical study design, and clinical research methodology
  • Proven track record driving clinical trial process improvements
  • Bring strong scientific and analytical skills to complex clinical development challenges
  • Are energized by contributing to therapies for rare and underserved patient populations

We are committed to building a workplace with an inclusive culture.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

  • annual bonuses or other incentive plans
  • equity awards
  • pension or retirement benefits
  • 401(k) company match
  • health and wellness programs
  • fitness centers
  • insurance benefits (e.g. medical, dental, vision, life and disability)
  • paid time off
  • family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$150,500.00 - $245,500.00

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