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Clinical Trial Risk Based Monitoring Jobs in Oregon

Parexel

OR · On-site

... risk/issues, and managing input from other internal and external partners * Conducts thorough ... Conducts and/or oversees site monitoring visits for clinical trials as needed * Provides oversight ...

Syneos Health/ inVentiv Health Commercial LLC

OR

Preferred experience with risk-based monitoring * Demonstrates understanding of clinical trial management financial principles and budget management * Knowledge of Good Clinical Practice/ICH ...

Syneoshealth

OR

Preferred experience with risk-based monitoring * Demonstrates understanding of clinical trial management financial principles and budget management * Knowledge of Good Clinical Practice/ICH ...

Care Access

OR · On-site

How This Role Makes a Difference The Clinical Trial Manager is a central leadership role within all ... Monitors and analyses project status to ensure successful completion of project parameters ...

Praxis Precision Medicines, Inc.

OR · On-site

This position is field based and requires 60-80% travel. The Opportunity Praxis is seeking a field-based Clinical Trial Liaison (CTL) to partner directly with clinical trial sites and drive high ...

Icon plc

Clinical Trial Liaison

Portland, OR · Remote

Job Advert Posting ICON's field-based Clinical Trial Liaisons are highly trained site engagement specialists who support clinical trials by providing scientific and clinical support to investigators ...

McKesson

OR

The Clinical Trial Central Screener (CTCS) will be responsible for centralized clinical support for patient screening at SCRIs network of community-based medical oncology practices. The CTCS will ...

McKesson

OR

The Clinical Trial Central Screener (CTCS) will be responsible for centralized clinical support for patient screening at SCRIs network of community-based medical oncology practices. The CTCS will ...

Mckesson

OR

The Clinical Trial Central Screener (CTCS) will be responsible for centralized clinical support for patient screening at SCRIs network of community-based medical oncology practices. The CTCS will ...

Lilly

OR · On-site

Provide legal, regulatory, and GCP compliance counsel on R&D Quality matters, including clinical trial risk management, inspection readiness, and response strategy for GCP inspections and related ...

IQVIA

Clinical Trial Nurse

Portland, OR · On-site

$50 - $60/hr

Clinical Trial Nurse - Per Diem - Portland, OR Work Set-Up: Local Travel - In-Home Patient Visits ... The actual base pay offered may vary based on a number of factors including job-related ...

TMAC

Australia The Clinical Trial Liaison (CTL) supports Global Development clinical study execution as ... issues based on site visits and contacts * Attend and present at investigator meetings, monitor ...

IQVIA

Clinical Trial Nurse

Eugene, OR · On-site

$50 - $60/hr

Clinical Trial Nurse - Per Diem - Eugene, OR Work Set-Up: Local Travel - In-Home Patient Visits Job ... The actual base pay offered may vary based on a number of factors including job-related ...

TMAC

Spain The Clinical Trial Liaison (CTL) supports Global Development clinical study execution as the ... issues based on site visits and contacts * Attend and present at investigator meetings, monitor ...

LivaNova

OR

Develops and executes risk based study management process and plan according to study-specific risk ... Create, update, and maintain site administrative files and trial master files (electronic and/or ...

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Clinical Trial Risk Based Monitoring information

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.

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 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.

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 Oregon? For Clinical Trial Risk Based Monitoring jobs in Oregon, the most frequently searched job titles are:
What job categories do people searching Clinical Trial Risk Based Monitoring jobs in Oregon look for? The top searched job categories for Clinical Trial Risk Based Monitoring jobs in Oregon are:
What cities in Oregon are hiring for Clinical Trial Risk Based Monitoring jobs? Cities in Oregon with the most Clinical Trial Risk Based Monitoring job openings:
Clinical Trial Risk Based Monitoring jobs near you

Risk Manager (Clinical Research)-USA

Indero

Portland, OR • On-site, Remote

Other

Posted 16 days ago

Job description

Description
The Risk Manager (Clinical Research) plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects. This position involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, supporting the seamless implementation of Risk-Based Study Management (RBSM) principles in a CRO or pharma industry.
RESPONSIBILITIES
More specifically, the Risk Manager must:
  • Provide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs.
  • Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications.
  • May have to coordinate with central monitor team and verify work.
  • Point sur provide budget recommendations, change orders.
  • Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT).
  • Guide Project Managers (PMs) in transferring identified risks to the appropriate tracking systems and ensure ongoing reviews.
  • Advise on developing functional plans to mitigate risks effectively.
  • Utilize available tools to conduct remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrity.
  • Facilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigations.
  • Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies.
  • Escalate risks or deliverables at risk to the PM, including scope changes.
  • Provide strategic input on risk characterization and reporting to leadership.
  • Take on additional responsibilities as required, ensuring qualifications and training align with assigned tasks.

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
Education
  • Bachelor's degree in a field relevant to clinical research;

Experience
  • Must have experience in a CRO or pharma industry
  • Minimum of 3 years in risk management within a clinical research setting.
  • Minimum 5 years of experience across clinical monitoring, data management, drug safety.

Requirements:
  • Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements.
  • Proficiency in Risk-Based Monitoring strategies, processes, and tools.
  • Mastery of MS Excel (sorting, filtering, pivot tables).
  • Advanced skills in analytical data visualization tools.
  • Knowledge of Lean Six Sigma and web based RACT tools.
  • Strong analytical and statistical understanding.
  • Excellent communication, negotiation, and leadership skills.
  • Ability to anticipate critical issues and develop proactive contingency plans.
  • Skilled in project workflows and cross-functional collaboration.
  • Training, mentoring, and organizational capabilities.
  • High level of autonomy.
  • Fluent in English (excellent oral and written).
  • Must be able to communicate clearly and effectively at all levels within the organization and with external customers.
  • Must be a fast learner and able to understand new concepts quickly.
  • Prioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demands.
  • Excellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring.
  • Broad working knowledge of the roles, functions and process of conducting clinical trials.
  • Must be able to manage time effectively, working with multiple functions and requirements.
  • Must have been involved in the use of trial management or data management systems.

Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
  • Flexible work schedule
  • Permanent full-time position
  • Company benefits package
  • Ongoing learning and development
  • Home-based position

Work location
Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
About Indero
A Global Clinical Leader in Dermatology and rheumatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years' experience in clinical research and trial delivery. Our full-service approach - which includes everything from protocol design and patient recruitment to trial monitoring and biometrics - provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in United States.

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