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.
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V1.0 02/2024
3928 Point Eden Way I Hayward, CA 94545 - Arcus Biosciences is an equal opportunity employer