Description Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient ...
Description Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in ...
Monitoring Oversight * Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials * Utilizing ...
Monitoring Oversight * Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials * Utilizing ...
Monitoring Oversight * Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials * Utilizing ...
Monitoring Oversight * Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials * Utilizing ...
... and oversight for assigned clinical studies. * Working closely with cross-functional teams ... Management of the 3rd party vendors such as CROs providing monitoring service and Flying Study ...
... and oversight for assigned clinical studies. * Working closely with cross-functional teams ... Management of the 3rd party vendors such as CROs providing monitoring service and Flying Study ...
... and oversight for assigned clinical studies. * Working closely with cross-functional teams ... Management of the 3rd party vendors such as CROs providing monitoring service and Flying Study ...
... and oversight for assigned clinical studies. * Working closely with cross-functional teams ... Management of the 3rd party vendors such as CROs providing monitoring service and Flying Study ...
Analyst, Consumer Compliance, Monitoring & Oversight
Fort Lee, NJ · On-site
$75K - $100K/yr
Identify trends or recurring issues in customer complaints/quality monitoring and provide feedback ... Qualifications: * 3+ years' experience providing oversight of sales, servicing, and/or collection ...
Analyst, Consumer Compliance, Monitoring & Oversight
Fort Lee, NJ · On-site
$75K - $100K/yr
Identify trends or recurring issues in customer complaints/quality monitoring and provide feedback ... Qualifications: * 3+ years' experience providing oversight of sales, servicing, and/or collection ...
Identify trends or recurring issues in customer complaints/quality monitoring and provide feedback ... Qualifications: * 3+ years' experience providing oversight of sales, servicing, and/or collection ...
Identify trends or recurring issues in customer complaints/quality monitoring and provide feedback ... Qualifications: * 3+ years' experience providing oversight of sales, servicing, and/or collection ...
As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data ...
As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data ...
As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data ...
As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data ...
As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data ...
As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data ...
As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data ...
As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data ...
The Manager, Clinical Monitoring supports global and regional clinical trial operations (CTO) and Clinical Monitoring management in the conduct and oversight of clinical site management and ...
The Manager, Clinical Monitoring supports global and regional clinical trial operations (CTO) and Clinical Monitoring management in the conduct and oversight of clinical site management and ...
Senior Director, Clinical Field Monitoring and Trial Operations
Bothell, WA · On-site
$261 - $309/hr
ResponsibilitiesMonitoring Strategy & Trial Oversight * Own and evolve Immunome's clinical monitoring strategy, including risk‑based monitoring (RBM) and fit‑for‑purpose monitoring models ...
New
Senior Director, Clinical Field Monitoring and Trial Operations
Bothell, WA · On-site
$261 - $309/hr
ResponsibilitiesMonitoring Strategy & Trial Oversight * Own and evolve Immunome's clinical monitoring strategy, including risk‑based monitoring (RBM) and fit‑for‑purpose monitoring models ...
New
Responsibilities Monitoring Strategy & Trial Oversight * Own and evolve Immunome's clinical monitoring strategy, including risk-based monitoring (RBM) and fit-for-purpose monitoring models (on-site ...
Responsibilities Monitoring Strategy & Trial Oversight * Own and evolve Immunome's clinical monitoring strategy, including risk-based monitoring (RBM) and fit-for-purpose monitoring models (on-site ...
Responsibilities Monitoring Strategy & Trial Oversight * Own and evolve Immunome's clinical monitoring strategy, including risk-based monitoring (RBM) and fit-for-purpose monitoring models (on-site ...
Responsibilities Monitoring Strategy & Trial Oversight * Own and evolve Immunome's clinical monitoring strategy, including risk-based monitoring (RBM) and fit-for-purpose monitoring models (on-site ...
Monitoring Oversight information
What is the difference between Monitoring Oversight vs Compliance Analyst?
| Aspect | Monitoring Oversight | Compliance Analyst |
|---|---|---|
| Required Credentials | Certifications like CAMS, CFE, or relevant industry training | Certifications such as CCEP, CRCM, or similar compliance credentials |
| Work Environment | Financial institutions, regulatory agencies, or corporate compliance teams | Financial services, healthcare, or corporate compliance departments |
| Employer & Industry Usage | Used to oversee ongoing monitoring activities and risk management | Used to analyze and ensure adherence to regulations and policies |
Monitoring Oversight focuses on supervising ongoing monitoring processes and risk management, while Compliance Analysts primarily analyze and ensure adherence to specific regulations. Both roles require compliance-related certifications and are integral to regulatory environments, but Monitoring Oversight emphasizes oversight functions, whereas Compliance Analysts focus on compliance analysis and reporting.
What are some common challenges faced by professionals in monitoring oversight roles, and how can they be addressed?
What is monitoring oversight?
What are the key skills and qualifications needed to thrive as a monitoring oversight specialist?

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Job description
Summary
The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in accordance with ICH GCP guidelines, local regulations, and applicable SOPs. The Clinical Monitoring Oversight Manager will work with Study Management Teams (SMT) to support Study Planning and Execution with drafting, implementing, and review of monitoring related study plans, identifying monitoring performance issues, managing site quality matters, assessing data quality metrics, documenting potential risks, escalating appropriate risks and issues, and communicating necessary action plans with cross functional Study Management Team. For blinded studies, the CMOM may act as the lead unblinded Clinical Operations contact, supporting unblinded study processes and associated oversight of monitoring expectations, including but not limited to the investigational product (IP) handling and accountability, management of the IXRS/IRT system, management of protocol deviations and unblinded safety reports, and documentation associated with these activities. The Clinical Monitoring Oversight Manager will conduct oversight monitoring visits, monitor and/or study process assessments, and site investigations.
This position can be in the Bay Area (in-house/hybrid) or can be remote. They will report to the Associate Director, Clinical Monitoring Operations.
Responsibilities
- Quality oversight of clinical monitoring activities by CROs and study vendors, as well as clinical trial conduct by Investigators and their clinical trial staff
- Serve as an escalation point for clinical monitoring issues for Arcus or CRO SMT and provide guidance or coaching, when necessary
- Lead the completion of quality oversight tasks, such as quality oversight visits, site visit report reviews, and the review and analysis of defined quality measures.
- Work with Arcus SMT Leads, Clinical Trial Managers, or CRO/vendor teams in resolving and escalating (when necessary) quality issues identified during the conduct of oversight monitoring activities.
- Maintain oversight of established monitoring metrics and communicate to cross functional Study Management Team in support of trial execution.
- Conducting or participating in Oversight Monitoring visits and/or site engagement/performance visits (may be blinded or unblinded visits)
- Drive proactive risk identification, mitigation, and issue management for monitoring-related and/or unblinded study components of the trial.
- Participate and support in audits and inspections; may be assigned owner and or contributor of quality event(s)/CAPA/Process Improvements as a result of monitoring-related findings, audit(s) and/ or inspection(s)
- Evaluate the quality and integrity of site practices, escalating quality and/or GCP issues with investigators and internal team as appropriate.
- Conduct site engagement visits as needed.
Qualifications
- Bachelor's degree, preferably in a scientific field
- 5+ years of related industry experience or equivalent, 4+ years of monitoring experience, with 1+ year of oversight monitoring, preferably in oncology
- Demonstrates core understanding of full life cycle of clinical trial activities
- Excellent communication skills both verbal and written are required
- Thorough understanding of ICH GCP guidelines
- Excellent understanding of Risk-Based Monitoring and Quality Management Principles
- Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors and clinical trial sites
- Excellent planning and organization skills
- Self-motivated, assertive, and able to function independently and as part of a team
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
- Proven problem solving and decision-making skills
- Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.)
- Ability and willingness to travel up to 50% of the time (domestic and international), may vary depending on trial needs
- Preference may be given to candidates with professional working proficiency in two or more languages.
#LI-Remote
V1.0 02/2024
3928 Point Eden Way I Hayward, CA 94545 - Arcus Biosciences is an equal opportunity employer
About Arcus Biosciences
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Hayward, CA, US
Year founded
2015