Job Title: Biomarker Associate (Sample Management)

Length of Assignment: 06 months

Location: South San Francisco? CA

General Position Summary:

This is an onsite position responsible for providing sample management support to ligand binding analysis and FACS-based biomarker laboratories. The samples are collected from preclinical and clinical studies in various therapeutic areas including oncology, neuroscience, immunology, and virology.

The Biomarker Associate I serve as a Bio-sample point of contact on assigned studies.

Collaborate with biomarker scientists, clinical operation teams, project managers and laboratory managers to coordinates all aspects of bio sample operations with minimal supervision.

Ensure all sample collections, storage and transfers are following protocols, regulatory requirements (ICH/GCP/GLP), ICF status, and project timelines. Identifies immediate needs on studies, projects, and tasks, and works closely with the lead Biomarker scientists on exploratory analysis activities and biomarker strategy.

As part of the team, contributes to innovation and continuous improvement activities in bio-sample collection, processing, and transfers.

Key Accountabilities/Core Responsibilities:

Track Clinical and laboratory samples and follows up with sites/study team, vendors, and/or CRO to resolve queries, discrepancy, reconciliation, and data entry as needed.

Execute and maintain processes for sample management, able to organize and manage large datasets, and provide regular summaries to team. Manage clinical bio-samples and storage equipment, including LN2 freezers.

Collaborate with Clinical Operations, Discovery, CQA and IT, contribute to the development and efficiency of departmental Laboratory Information Management System (LIMS).

Assist in the planning and organization of collection and shipping of bio-samples from investigator sites or centralized locations and subsequent delivery to analytical laboratories or company site.

Partner with Biomarker Leads to ensure the delivery of bio-sample data in accordance with study timelines. Provide operation support for Senior Biomarker Associates and Biomarker Leads.

Support relationships with laboratory vendors, provide input into trial-specific agreements and assess service level commitments of labs involved in sample analysis. Ensure issues are resolved or escalated in a timely manner.

Assist to review laboratory vendor invoices to ensure appropriate work has been completed. Contributes to functional process and system improvements to ensure samples are collected, processed, and analyzed appropriately.

Qualifications:

Proficiency in MS office including Word, Excel, PowerPoint, and other applications.

Previous experience and proficiency in utilizing LIMS preferred.

Previous HIPAA and/or Human Subject Protection knowledge preferred.

Knowledge of processing and storage management of human bio-specimen preferred.

Effective team player and ability to collaborate with cross functional clinical study teams.

Ability to oversee bio-sample management activities across multiple clinical trials.

Demonstrated ability to balance multiple priorities in a fast paced, team-based environment and work independently when necessary.

Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and team members. Hands-on experience in handling clinical biological samples.

Demonstrated strengths in planning, organizational, analytical skills, time management, problem solving, and attention to detail. Proven critical reasoning skills including the identification and resolution of complex problems. BA/BS in Biology, Pharmacology or equivalent, with/or 1 to 3 years of relevant industry experience.

Experience in clinical research or bio-sample handling at either an investigational site, pharmaceutical/biotech company, or equivalent