Overview
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 CMOM will work with Study Management Teams (SMT) to support study planning and execution, drafting, implementing, and reviewing 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 the 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 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 CMOM 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 remote. They will report to the Associate Director, Clinical Monitoring Operations.
Responsibilities
* Ensure quality oversight of clinical monitoring activities by CROs and study vendors, and clinical trial conduct by investigators and their 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 analysis of defined quality measures.
* Collaborate with Arcus SMT Leads, Clinical Trial Managers, or CRO/vendor teams to resolve and, when necessary, escalation of quality issues identified during oversight monitoring activities.
* Maintain oversight of established monitoring metrics and communicate them to the cross‐functional Study Management Team to support trial execution.
* Conduct or participate in oversight monitoring visits and/or site engagement/performance visits (blinded or unblinded).
* Drive proactive risk identification, mitigation, and issue management for monitoring‐related and/or unblinded study components.
* Participate and support audits and inspections; may be assigned owner and/or contributor of quality events and CAPA/process improvements resulting from monitoring‐related findings.
* Evaluate the quality and integrity of site practices, escalating quality and GCP issues with investigators and internal teams 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, with 4+ years of monitoring experience; 1+ year of oversight monitoring, preferably in oncology.
* Demonstrated core understanding of the full lifecycle of clinical trial activities.
* Excellent communication skills, both verbal and written.
* 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 with study teams, cross‐functional team members, external partners/vendors, and clinical trial sites.
* Excellent planning and organization skills.
* Self‐motivated, assertive, able to function independently and as part of a team.
* Strong interpersonal and negotiation skills and 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 with clinical trial web‐based systems (e.g., EDC, IRT, CTMS, eTMF).
* Ability and willingness to travel up to 50% of the time (domestic and international) as needed.
* Preference for candidates with professional working proficiency in two or more languages.
Equal Opportunity Statement
Arcus Biosciences is an equal opportunity employer.
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