VS-Biomarker Sample Management Associate -South San Francisco, CA at Rangam Infotech Private Limited

100% Onsite

General Position Summary/Purpose:

• 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