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Clinical Trial Risk Based Monitoring Jobs in Oregon

Care Access

OR

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 ...

Pulse Biosciences

OR

... risk mitigation plans to meet study milestones. * Supervise Contract Research Organizations (CROs), core labs (e.g., ECG/Holter monitoring), and external vendors to ensure deliverables are met on ...

Natera

OR · On-site

Use tracking tools to monitor performance metrics. Develop SOPs and continuous process improvement ... MRD based clinical trial landscapes Expert-level understanding of clinical trial design and the ...

TMAC

$65K - $87K/yr

... based extension to support the company's clinical trial programs. ESSENTIAL DUTIES AND RESPONSIBILITIES Site and Investigator Partnerships • Create investigator engagement plans to support site ...

Spyre Therapeutics

OR · On-site

$215K - $230K/yr

... monitoring of key trial metrics, risk-based quality oversight and study close-out. * Interpret ... Write clinical science sections of meeting packages and assist in the development and review of ...

Motive

OR

As the trial process lead, Trial Success Managers (TSMs) will manage key elements of our proof-of ... risk management, and coaching techniques * Create and deliver effective onsite and web-based ...

New

Natera

OR

... 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

Thermo Fisher Scientific

OR

$80K - $125K/yr

Acting as a site processes specialist, you will ensure that the trial is conducted in accordance ... Ability to manage Risk Based Monitoring concepts and processes • Good oral and written ...

Aptive

Clinical Research Protocol Specialist

... trial and research protocols from concept development through final protocol submission and ... Monitor progress and identify risks that could impact protocol development timelines or regulatory ...

Syneos Health/ inVentiv Health Commercial LLC

OR · On-site

This is a fully remote, US-based opportunity where you will play a critical role in the operational ... Monitor study performance metrics and proactively identify areas requiring intervention * Ensure ...

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Clinical Trial Risk Based Monitoring information

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 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 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 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 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:
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Clinical Trial Risk Based Monitoring jobs near you
Clinical Trial Manager

Clinical Trial Manager

Care Access

OR

Other

Medical, Dental, Vision, Retirement, PTO

Posted 16 days ago

Job description

How This Role Makes a Difference

The Clinical Trial Manager is a central leadership role within all (study) operations. The CTM is responsible to drive the successful execution of protocols or projects, including within the decentralized trial model when applicable, from strategic planning through close out within agreed upon timelines, budget, alignment with all applicable SOPs and regulatory requirements. This role is critical to operationalize trials or projects across the organization and site network within Care Access Research.

How You'll Make An Impact
  • Drives and Manages studies or projects according to scope of work, timelines, and quality standards.
  • Supports building a strategy to deliver the trial or project as per protocol and timelines. 
  • Monitors and analyses project status to ensure successful completion of project parameters, milestones, timetables.
  • Understands proactively manages risks on trials or projects and implements mitigations whilst working in a cross functional team.
  • Acts as principal liaison between Sponsor and Care Access by facilitating the flow of information between Care Access and client.
  • Appropriately escalates any issues or potential issues as per escalation pathways; and provides timely project updates to upline management and/or Senior Leadership at Care Access.
  • Coordinates a cross functional team to support delivery of the clinical trial.
  • Holds teams accountable for delivery and success of the trial.
  • Leads teams to successfully deliver in their areas.
  • Coordinates activities of all functional departments and vendors involved in the project.
  • Works with team and management to develop plans/guidelines for project implementation using Care Access tools.
  • Identifies data and analytics required to allows data-driven decisions and continuously monitors ongoing project performance.
  • Evaluates growth opportunities of current engagement or potential engagements; helps develops the strategy for various initiatives.
  • Ensures teams are entering and updating internal tracking tools.
  • Works with team to identify potential risks, develop contingency plans.
  • Provides Sponsor with timely project updates, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work 
  • May discuss and obtain feedback from Sponsors regarding Care Access's performance to date.
  • Plans and communicates to team members to study specific tasks and priorities for projects.
  • Delegates, as appropriate, assigned responsibilities to project team members.
  • Liaises with managers in all functional areas within Care Access to optimize performance and utilization of the project team members.
  • Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed.
  • Schedules, leads, and follows up on pre-identified meetings. Documents, sends meeting minutes and follows-up on action items. May be internal and/or external.
  • Maintains project logs and trackers.
  • Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels.
  • Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.
  • Escalates identified findings from periodic quality reviews and peer feedback reports.
  • Collaborates with fellow CTMs and department leadership on best practices.
The Expertise Required
  • Exceptional strategic thinking and problem-solving skills to drive Care Access goals while fostering and maintaining a strong client relationship.
  • Effective leadership skills, strong communication competency, and proven ability to foster team productivity and cohesiveness.
  • Ability to show flexibility by pivoting workflows and adjusting priorities as needed.
  • Ability to work independently, organize work with attention to detail and accuracy; demonstrated skill in assessing timelines and coordinating numerous assignments and projects simultaneously under heavy and fluctuating workloads and
  • conflicting deadlines.
  • High degree of discretion in dealing with confidential information.
  • Ability and willingness to work flexible hours when needed.
  • Ability to mentor junior team members.
  • Excellent written, verbal, and interpersonal communication skills.
  • Comfortable in a fast-paced environment.
Certifications/Licenses, Education, and Experience
  • Minimum Education:
    • Bachelor's degree
  • Minimum Experience:
    • Must have clinical trial experience.
    • Must have 5+ years of experience in the clinical trial/pharmaceutical industry.
    • Must have 2-3+ years in project management including client management.
    • Site experience, preferably in a site network.
    • Experience with oversight of external vendors (e.g., e-consent vendor).
    • Experience collaborating and leading cross-functional teams in a matrix environment.
    • Experience managing multiple projects across various therapeutic areas.
    • Experience anticipating and resolving problems on projects.
    • Experience reporting project details to various stakeholders within the company and outside of the company
    • Decentralized clinical trial experience, preferred.
    • Experience with strategy consulting, preferred.
    • PMP Certification, preferred.
How We Work Together
  • Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
  • Travel: This is a remote position with less than 25% national travel requirements. Occasional planned travel may be required as part of the role.
  • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

The expected pay range for this role is $90,000 - $110,000 USD per year for full time team members.

Benefits & Perks (US Full Time Employees)
  • Paid Time Off (PTO) and Company Paid Holidays
  • 100% Employer paid medical, dental, and vision insurance plan options
  • Health Savings Account and Flexible Spending Accounts
  • Bi-weekly HSA employer contribution
  • Company paid Short-Term Disability and Long-Term Disability
  • 401(k) Retirement Plan, with Company Match 

Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29-38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. 

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