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Clinical Trial Risk Based Monitoring Jobs in Oregon

... of clinical trial execution at investigator sites and ensure the client's oversight of CRO ... Utilizes a risk-based approach to review critical to quality items at the site level and study ...

Inspection Readiness Manager

OR · On-site +1

$114.75K - $143.24K/yr

... clinical trial risk management support primarily to Clinical Program Operations, to ensure ... Stock-based long-term incentives * Award-winning time-off plans and bi-annual company-wide ...

OR · On-site

Ensures that the Global Head of Trial Operations is informed in case an identified issue/risk could ... Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global ...

OR · On-site

... clinical trial start-up and execution. This role ensures vendors are qualified, contracted, and ... Monitor vendor performance, proactively raise risks based on historical knowledge, and escalate ...

... monitoring plans, case report forms, training plans and engagementmaterials Ensure trial master ... Escalate findings to senior management and/or leadership according to risk/severity. Participate in ...

... ctDNA-based monitoring. * Lead the design and implementation of clinical studies and treatment ... Minimum 3 years of clinical trial experience in academic, biotech, or pharmaceutical settings

... a clinical trial. Monitoring Responsibilities and Study Conduct: * Ensure proper conduct of ... Risk: * Maintain thorough understanding of the product, protocol and therapy area in sufficient ...

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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 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:
Director, Clinical Trial Strategy & Optimization

Director, Clinical Trial Strategy & Optimization

Mckesson

Remote

Full-time

Posted 6 days ago


McKesson rating

7.8

Company rating: 7.8 out of 10

Based on 198 frontline employees who took The Breakroom Quiz

39th of 70 rated pharmaceutical


Job description

It's More Than a Career, It's a Mission.


Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission


People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

The Director, Clinical Trial Strategy & Optimization is responsible for leading efforts to streamline and enhance clinical trial processes to accelerate study delivery while improving quality, consistency, and operational effectiveness. This role drives critical strategic initiatives across the clinical trial lifecycle, identifies opportunities for process improvement, and partners closely with cross-functional teams to implement scalable solutions that support business goals and high-quality trial execution.

Duties include but are not limited to:

  • Identify opportunities to optimize clinical trial processes across the study lifecycle and drive process changes that improve speed, quality, consistency, and operational efficiency.

  • Lead cross-functional teams in the design, implementation, and sustainment of process improvements that support high-quality and timely clinical trial delivery.

  • Ensure site perspectives are represented in process redesign efforts and partner with site stakeholders to bring them along through change planning, communication, training, and adoption.

  • Assess current-state workflows, identify root causes of inefficiencies, and prioritize improvement initiatives based on business impact, feasibility, and alignment with strategic goals.

  • Develop and monitor key performance indicators, dashboards, and reporting to track process improvement outcomes, risks, and opportunities across clinical trial operations.

  • Report progress, insights, and recommendations to executive leadership, providing clear updates on strategic initiatives, implementation status, and measurable impact.

  • Establish governance, documentation, and standard work to support consistent execution of updated processes and promote a culture of continuous improvement.

  • Build strong partnerships across clinical, operational, quality, technology, and site teams to align stakeholders, remove barriers, and deliver changes to process.

  • Collaborate with sites, sponsors, contract research organizations, and vendors as needed to support process alignment, operational readiness, and successful implementation of change.

  • Ensure process improvements are implemented in alignment with quality standards, regulatory requirements, and organizational priorities while maintaining focus on sustainable execution.

Mandatory: The following are mandatory expectations of all SCRI employees.

  • Practices and adheres to the "Code of Conduct" philosophy and "Mission and Value Statement."

  • During your employment with SCRI, you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.

Minimum Qualifications:

  • Bachelor's Degree required

  • At least 5 years of experience in clinical trials is required

  • Knowledge of scientific, medical, and regulatory terms

  • Knowledge of ICH Guidelines, GCP, and CFR Title 21

  • Clinical research process knowledge with an understanding of medical terminology

  • Sophisticated problem-solving skills

  • Highly organized

  • Flexible and adaptable

  • Strong communication skills; persuasive, encouraging, motivating, and inspiring; the ability to listen and understand; the ability to communicate the complex in simple terms

  • Ability to establish relationships - develop strategic relationships within and outside of direct organization

  • Facilitation and communication skills - able to drive plans, decisions, and resolve issues through facilitation of groups or individuals

  • Process improvement skills and techniques

  • Change management skills and techniques

  • Excellent active listening skills

  • Experience working in a matrix environment and with virtual team members / stakeholders

  • Ability to thrive in team environments of considerable change

  • Ability to define vision and lead through change

  • Ability to partner with individuals at all levels of management and across organization boundaries

  • Ability to work across many teams to identify business opportunities and drive to consensus

This is a remote position based in the United States. Relocation and visa sponsorship are not available.

Interested candidates should submit their application through https://www.scri.com/careers/. Applications will be accepted through May 29th, 2026. Please ensure all required materials are included as outlined in the posting.

About Sarah Cannon Research Institute


Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

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McKesson job postings are posted on our career site: careers.mckesson.com.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.


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