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Clinical Trial Risk Based Monitoring Jobs in Maryland

Ambu

Clinical Trial Manager

Columbia, MD · On-site

Monitor enrollment, site performance, study milestones, and overall study progress while ... Provide regular study status updates, risk assessments, and recommendations to project stakeholders.

Tenacity Solutions LLC

Be Seen First

Clinical Research Associate

North Bethesda, MD · On-site

$115K - $135K/yr

Clinical trial documentation * Source data verification * CAPA development * Risk-based monitoring * Experience monitoring multi-site clinical trials. * Experience reviewing electronic medical ...

ICON

Senior Clinical Research Associate

Baltimore, MD · On-site +1

Solid tumor clinical trial experience is required * Experience utilizing Veeva systems is highly ... Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and ...

VENESCO, LLC

Clinical Trial Manager

Fort Detrick, MD

$125K - $143K/yr

Monitor study metrics and status reports. * Coordinate interactions among sites, CROs, sponsors ... discrimination based on race, ethnicity, religious affiliation, gender, gender identity or ...

VENESCO LLC

Clinical Trial Manager

Fort Detrick, MD · On-site

Monitor study metrics and status reports. * Coordinate interactions among sites, CROs, sponsors ... discrimination based on race, ethnicity, religious affiliation, gender, gender identity or ...

Axle

Clinical Research Coordinator

Bethesda, MD · On-site

$26 - $34.50/hr

... trial implementation * Develop risk mitigation and response plans * Monitor identified risks ... harassment based on age, race, gender, religion, national origin, disability, marital status ...

Axle

Clinical Research Coordinator

Bethesda, MD

$26 - $34.50/hr

... trial implementation * Develop risk mitigation and response plans * Monitor identified risks ... harassment based on age, race, gender, religion, national origin, disability, marital status ...

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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 Maryland?

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

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

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

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

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

Clinical Trial Risk Based Monitoring jobs near you

Clinical Trial Manager

Ambu

Columbia, MD • On-site

Full-time

Posted 9 days ago

Job description

Clinical Trial Manager
City: Columbia, MD
Country/Region: United States
State:
Business Area: Clinical Research
Department: Clinical Affairs
Employment Type: Full-time
Req ID: 10220
Job Title: Clinical Trial Manager
Reports to: Director, Clinical Data Acquisition
Location: Remote or Columbia, MD
POSITION SUMMARY
Ambu is advancing the future of endoscopy through data-driven innovation. As part of our growing Clinical Data Acquisition team, the Clinical Trial Manager will play a critical role in generating the high-quality clinical data needed to support the development of Ambu's next generation of AI-powered Endointelligence solutions.
Unlike traditional pharmaceutical clinical trial roles, this position focuses on the planning, execution, and oversight of medical device clinical studies designed to acquire clinical data that supports product innovation, algorithm development, and clinical validation. Working cross-functionally with Clinical Affairs, R&D, Software Engineering, Regulatory Affairs, Quality, and Commercial teams, the Clinical Data Manager will manage clinical studies from planning through closeout while ensuring compliance with applicable regulatory requirements, quality standards, and study timelines. This is a highly collaborative, hands-on role with significant interaction across internal teams, clinical sites, and external partners. As part of a newly established function, this individual will also help build scalable processes and contribute to the continued growth of Ambu's clinical data capabilities.
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
  • Lead the planning, execution, monitoring, and close-out of clinical studies in accordance with ISO 14155, Good Clinical Practice (GCP), and applicable regulatory requirements.
  • Partner with cross-functional stakeholders to support protocol development, study design, and operational planning.
  • Identify, qualify, initiate, and manage clinical study sites across North America and Europe, as needed.
  • Perform or oversee site monitoring activities, including coordination with Contract Research Organizations (CROs) when applicable.
  • Serve as the primary operational liaison between clinical sites, investigators, internal stakeholders, and external vendors.
  • Support study budgets, contracts, site agreements, and vendor management in collaboration with internal partners.
  • Monitor enrollment, site performance, study milestones, and overall study progress while proactively identifying and resolving operational challenges.
  • Maintain study documentation and ensure compliance with internal quality systems, regulatory standards, and applicable SOPs.
  • Contribute to the development, implementation, and continuous improvement of Clinical Operations processes and Standard Operating Procedures (SOPs).
  • Support internal and external audits and regulatory inspections as required.
  • Provide regular study status updates, risk assessments, and recommendations to project stakeholders.
  • Travel to investigator sites as needed to support study execution and monitoring activities.

QUALIFICATIONS
REQUIRED:
  • Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another relevant scientific discipline.
  • Several years of clinical operations or clinical trial management experience within the medical device, biotechnology, or healthcare industry.
  • Strong working knowledge of ISO 14155 and Good Clinical Practice (GCP) requirements for medical device clinical investigations.
  • Experience managing investigator sites, study monitoring, and overall clinical study execution.
  • Demonstrated ability to manage multiple studies and priorities simultaneously.
  • Strong organizational, project management, and stakeholder management skills.
  • Excellent written and verbal communication skills.
  • Ability to work effectively within a global, cross-functional organization.

PREFERRED:
  • Experience supporting AI-enabled medical technologies, digital health, imaging, or software-based medical devices.
  • Experience working with Contract Research Organizations (CROs) from either the sponsor or vendor perspective.
  • Exposure to protocol development, regulatory submissions, or clinical study design.
  • Experience supporting global or multi-center clinical studies.

WHO YOU ARE
  • You are a proactive and collaborative clinical operations professional who enjoys building new capabilities and solving complex challenges.
  • You balance strong attention to detail with the ability to see the bigger picture and thrive in dynamic, cross-functional environments.
  • Take a practical, solution-oriented approach while maintaining regulatory compliance.
  • Build trusted relationships with investigators, clinical sites, and internal stakeholders.
  • Communicate effectively across technical and non-technical teams.
  • Enjoy working in fast-paced environments where processes continue to evolve.
  • Are motivated by improving patient care through innovation and high-quality clinical data.

WHY JOIN AMBU?
This is an exciting opportunity to join a newly established team helping shape the future of AI-enabled healthcare. At Ambu, you'll have the opportunity to:
  • Help build a new clinical data acquisition function from the ground up.
  • Work at the intersection of clinical research, medical devices, software, and artificial intelligence.
  • Collaborate with global teams across Clinical Affairs, R&D, Software, Regulatory, and Commercial.
  • Make a meaningful impact on innovative technologies that improve patient care worldwide.
  • Grow your career within a global medical technology company committed to innovation and continuous improvement.

#Remote (LI)
About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.
For more information, please visit ambu.com or follow us on LinkedIn.
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About Ambu

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

501 - 1,000 Employees

Headquarters location

Noblesville, IN, US

Year founded

1937

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