Clinical Monitoring Oversight Manager - Contractor

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. Work with Study Management Teams (SMT) to support study planning and execution, including drafting, implementing, and reviewing monitoring-related study plans, identifying monitoring performance issues, managing site quality matters, assessing data quality metrics, documenting potential risks, escalating risks and issues, and communicating action plans with cross-functional teams.

For blinded studies, act as the lead unblinded Clinical Operations contact, supporting unblinded study processes and associated oversight of monitoring expectations, including investigational product (IP) handling and accountability, management of the IXRS/IRT system, protocol deviations, unblinded safety reports, and related documentation.

This position can be located in the Bay Area (in-house/hybrid) or remote, and reports to the Associate Director, Clinical Monitoring Operations.

Responsibilities

• Provide quality oversight of clinical monitoring activities by CROs and study vendors, as well as 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 the review and analysis of defined quality measures.
• Work with Arcus SMT Leads, Clinical Trial Managers, or CRO/vendor teams to resolve and escalate (when necessary) quality issues identified during oversight monitoring activities.
• Maintain oversight of established monitoring metrics and communicate to cross-functional Study Management Team in support of trial execution.
• Conduct or participate in oversight monitoring visits and/or site engagement/performance visits (may be blinded or unblinded).
• 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 events, CAPA, or process improvements resulting from monitoring-related findings, audits, and/or inspections.
• 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 the full life cycle of clinical trial activities.
• Excellent verbal and written communication skills.
• 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 members, 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.
• Proven problem-solving and decision-making skills.
• Excellent IT Microsoft skills and experience using clinical trial management web-based systems (e.g., EDC, IRT, CTMS, eTMF).
• Ability and willingness to travel up to 50% of the time (domestic and international), varying by trial needs.

Preference may be given to candidates with professional working proficiency in two or more languages.