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Clinical Trial Risk Based Monitoring Jobs in Colorado

Clingroup

Study Monitor

Fort Collins, CO · Remote

$33.25 - $45.25/hr

We're actively seeking aNorth American based Study Monitor to join our expanding Field Clinical ... monitoring practices, this role contributes to the integrity of clinical trial outcomes and ...

Medpace, Inc.

CO

Associate Clinical Trial Manager At this event, Medpace is seeking to meet candidates with PhDs and/or Post-Doctoral Research experience for a full-time, office-based Associate Clinical Trial Manager ...

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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.

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Clinical Trial Risk Based Monitoring jobs near you
Senior Director, Clinical Data Management

Senior Director, Clinical Data Management

Umoja Biopharma

Louisville, CO • On-site, Remote

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 24 days ago

Job description

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma - Your Body. Your Hope. Your Cure.
POSITION SUMMARY
The Senior Director, Clinical Data Management will provide strategic and operational leadership for all clinical data management activities across Umoja's clinical development programs. This role sits within the Clinical organization and is accountable for ensuring the integrity, quality, and regulatory compliance of clinical trial data from protocol development through database lock and regulatory submission.
This individual will lead the planning, execution, and oversight of data management activities, clinical systems, and external vendors, while building scalable processes and capabilities to support a growing clinical pipeline. The role partners closely with Clinical Development, Clinical Operations, Biostatistics, Translational Medicine, Regulatory Affairs, and external partners like CROs to ensure timely delivery of high quality, decision-read-y- clinical data.
This role will be an Individual Contributor and will lead a matrixed team of vendors (CROs) and contractors to start. This person will be responsible for building out a future team.
This role will ideally be based in Seattle, WA or Louisville, CO but can be remote within the US. If remote, travel to Umoja Headquarters will be required at least once per quarter.
CORE ACCOUNTABILITIES
Specific Responsibilities include:Hands-On Clinical Data Management Execution (as needed while building CDM team)
  • Serve as the primary clinical data management lead for assigned clinical trials, with direct accountability for data quality, timeliness, and inspection readiness from protocol development through database lock.
  • Perform detailed protocol review with a focus on data flow, endpoints, data collection strategy, and facilitation of downstream analysis requirements.
  • Lead hands-on CRF design and review, ensuring alignment with protocol objectives-, statistical analysis plans, and regulatory expectations.
  • Develop, review, and approve data management plans (DMPs), database specifications, edit check specifications, data transfer agreements, and data review plans.
  • Actively participate in EDC system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change control.
  • Perform ongoing hands-on data review, query trend analysis, and proactive data cleaning to ensure high-quality, analysis ready- datasets.

Technical Oversight & Data Quality
  • Partner with Clinical Operations and other groups to define and implement data quality standards, reconciliation strategies, and risk based-monitoring approaches for clinical data.
  • Lead hands-on-oversight of external CROs and vendors delivering data management services, including detailed review of deliverables, issue resolution, and escalation management.
  • Directly review and contribute to data listings, data exports, and interim analysis datasets in partnership with Biostatistics and Statistical Programming.
  • Ensure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standards.
  • Support inspection readiness activities by authoring, reviewing, and maintaining data management documentation and responding directly to audit and inspection findings.

Cross Functional Collaboration
  • Partner closely with Clinical Operations to align data management activities with study execution, site operations, monitoring strategies, and operational reporting needs.
  • Collaborate with Biostatistics and Statistical Programming to ensure smooth handoff of clean, well documented- datasets for analysis and reporting.
  • Provide technical data management expertise to Regulatory Affairs in support of clinical study reports, INDs, BLAs, and other regulatory submissions.
  • Serve as the clinical data management subject matter- expert on study teams, governance forums, and internal reviews.

Process & Systems Ownership
  • Own and continuously improve clinical data management processes, tools, and SOPs to support efficient execution in a growing organization.
  • Evaluate, implement, and optimize clinical data systems and technologies (e.g., EDC, IRT, eCOA) to enhance data quality, traceability, and scalability.
  • Contribute hands-on to vendor selection, scope definition, and budgeting for data management services and systems.

The successful candidate will have:
  • Bachelor's degree or higher in life sciences, health informatics, computer science, or a related discipline with a minimum of 15 years of experience. Equivalent combinations of education and experience will be considered.
  • Significant experience in clinical data management within the biotechnology or pharmaceutical industry, including 8+ years of leadership of data management functions for clinical trials.
  • Demonstrated experience overseeing CROs and external vendors delivering clinical data management services.
  • Strong working knowledge of clinical trial processes, EDC systems, data standards, and regulatory expectations for clinical data.
  • Proven ability to lead teams, manage complex programs, and collaborate effectively in a fast-paced, matrixed environment.
  • Excellent written and verbal communication skills.

Preferred Qualifications:
  • Experience supporting oncology and/or cell or gene therapy clinical development programs.
  • Experience building or scaling clinical data management capabilities in a growing biotech organization.
  • Prior involvement in regulatory submissions and inspection readiness activities.

Physical Requirements
  • Preference to work onsite at least 2 days/week in our Seattle, WA or Louisville, CO location. If remote, the ability to travel to Seattle, WA at least once per quarter.
  • Ability to sit for prolonged periods of time.

Salary Range: $247,400 - $305,600
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

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