[Hiring] Senior Manager, Biosample Operations @Arcus Biosciences

Role Description

The Senior Manager, Biosample Operations Contractor will be responsible for planning, implementing, managing, and driving biological sample logistics across Phase I-IV Clinical Trials. This role is an essential member of the Clinical Operations function and must be able to collaborate with the cross-functional teams both internal and external. This position reports to the Head of Biosample Operations, Business Operations and Enablement, Clinical Operations. This position is remote or if bay area in-house/hybrid, depending on experience.

• Expertly advise on and deliver the sample strategy for clinical trials within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP.
• Accountable for the implementation, execution and oversight of sample collection, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality.
• Independently review clinical study protocols, informed consents, laboratory documents, case report forms, laboratory scopes of work, laboratory budgets and invoices.
• Review and file necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
• Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of clinical trial samples, including oversight of sample collection at sites, shipment to vendor for processing/testing, sample queries and final sample disposition.
• Be the primary point of contact for study team related to sample operations for assigned clinical trials.
• Collaborate with cross-functional study teams to ensure delivery of samples per project milestones.
• Track and report on sample management status and address issues proactively.
• Lead innovation and process improvement activities for Biosample Operations and/or Clinical Operations functions.
• Mentor junior Biosample Managers and Biosample Specialists.

Qualifications

• Bachelor’s degree, preferably in a scientific or healthcare field or equivalent combined education.
• 7+ years of clinical trial management experience preferred.
• 4+ years of Biosample Operations experience required.
• Advanced understanding of clinical trial processes from study start-up through study closure related to sample collection, logistics, transit, storage, central tracking and global requirements.
• Excellent knowledge of ICH GCP and GLP guidelines.
• Proven ability to independently establish priorities, work with a strong sense of urgency and collaborate effectively with the study team, cross-functional team members and external partners/vendors across multiple projects.
• Advanced project management skills with the ability to identify risks and issues as well as propose appropriate measures as required.
• Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners).
• Proficiency with Microsoft Office.
• Excellent verbal and written communication.
• Proven problem solving and decision-making skills.
• Ability and willingness to travel ~10% (domestic/international).

Company Description