Clinical Monitoring Oversight Manager (Contractor) (Office OR Remote)

The Clinical Monitoring Oversight Manager (contractor) will provide oversight of trial monitoring activities to ensure data quality and patient safety in accordance to GCP and ICH guidelines, local regulations, and applicable SOPs. The Clinical Monitoring Oversight Manager will work with Clinical Operations Leadership Team to develop necessary procedures and tools to support Clinical Trial Managers with drafting, implementation and review of monitoring 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. The Clinical Monitoring Oversight Manager will also conduct oversight monitoring visits, train Clinical Trial Managers to perform oversight monitoring visits, and identify appropriate methods/ processes for conducting oversight monitoring visits globally. This position is remote or if in bay area in-house/hybrid. They will report to a member of the Clinical Operations Leadership Team.

Responsibilities

• Quality oversight of clinical monitoring activities by CROs and clinical trial conduct by Investigators and their clinical trial staff

• Serve as an escalation point for clinical monitoring issues for Arcus Clinical Trial Managers 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 Clinical Trial Managers or CRO management staff in resolving and escalating (when necessary) quality issues identified during the conduct of oversight monitoring activities

• Conducting or participating in oversight Monitoring visits

• Identify, develop, improve, and implement the necessary procedures and documentation for quality oversight activities

• Train newly onboarded team members to Arcus oversight monitoring and provide ongoing training as identified

• Maintain oversight of established monitoring metrics and communicate to cross functional Study Management Team in support of trial execution

• Escalate identified risks appropriately and timely

• Participate and support in audits and inspections. Respond and assist in CAPA/ Process Improvements as a result of audit and/ or inspections

• Evaluate the quality and integrity of site practices, escalating quality and/or GCP issues with investigators and internal team as appropriate

• Mentors junior staff

• Conduct site engagement visits as needed

Requirements

• Bachelor's degree, preferably in a scientific field

• Minimum 7 years of related industry experience in the pharmaceutical industry or equivalent, Minimum of 5 years of monitoring experience, with at least 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 approximately 50% of the time (domestic and international), may vary depending on trial needs

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets