Senior Manager, Biosample Operations - Contractor

Description

Summary

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.

Responsibilities

• 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. This includes but is not limited to 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 (interpersonal, relationship management) 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).