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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 Ohio?

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

What job categories do people searching Clinical Trial Risk Based Monitoring jobs in Ohio look for?

The top searched job categories for Clinical Trial Risk Based Monitoring jobs in Ohio are:

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

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

Clinical Trial Risk Based Monitoring jobs near you

Associate Director, Clinical Trial Management

Medpace, Inc.

Cincinnati, OH • On-site

$32.25 - $44/hr

Other

Medical, Retirement, PTO

Re-posted 27 days ago

Medpace rating

8.6

Company rating: 8.6 out of 10

Based on 12 frontline employees who took The Breakroom Quiz

14th of 74 rated research

Job description

Job Summary
Medpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers / Project Managers to join our Clinical Trial Management Group across our US offices. Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular, Renal, Gastrointestinal, Endocrine/Metabolic, Infectious Disease, Neuroscience, and more. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.
Responsibilities
  • Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
  • Serve as primary Sponsor contact for operational project-specific issues and study deliverables
  • Maintain in depth knowledge of protocol, therapeutic area, and indication
  • Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
  • Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
  • Develop operational project plans
  • Manage risk assessment and execution
  • Manage study vendors where applicable
  • Manage site quality and monitoring deliverables

Qualifications
  • Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred
  • Experience in Phases 1-4; Phases 2-3 preferred
  • 5+ years as a project/clinical trial manager within a CRO;
  • Management of overall project timeline
  • Bid defense experience, preferred
  • Strong leadership skills

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace?
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
    • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture
    • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
    • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development
    • Office based environment with on-site mentors
    • Defined career paths with clear advancement opportunities
    • Industry renowned onboarding and training programs designed to accelerate professional development
    • Ongoing training and continuous learning opportunities throughout your career
    • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits
    • Competitive compensation programs that recognize and reward performance
    • Comprehensive health, wellness, retirement, and PTO benefits
    • Office based culture with occasional WFH that provides flexibility for eligible positions after training
    • Company-sponsored social events and intramural sports

Cincinnati Headquarters Experience
    • A modern corporate campus designed to support collaboration and productivity
    • Multiple on-site dining options in the heart of Madison Square
    • Free on-site parking
    • Convenient access to on-site 24-7 fitness and wellness facilities

What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.

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About Medpace

Sourced by ZipRecruiter

Medpace is a globally recognized clinicial contract research organization (CRO) based in Cincinnati, OH, in the United States. Established in 1992, it operates in the healthcare sector, providing scientifically-driven outsourcing solutions for the development of drugs and medical devices. It offers comprehensive services like full-service clinical development services, regulatory affairs management, clinical pharmacology, data management, statistical analysis, and medical writing. By applying a scientifically-driven, therapeutically-focused, and patient-centric approach, Medpace's mission is to accelerate the global development of safe and effective medical therapies.

Industry

Medical equipment and supplies manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Cincinnati, OH, US

Year founded

1992

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