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Sample Manager

Company: Principia Biopharma Inc.
Location: Framingham
Posted on: June 7, 2021

Job Description:

Position Overview:

The Sample Manager is an expert in biological sample handling, ensuring the procedures for collection, storage and shipment of specimens are followed for measurements of clinical samples of R&D Translational Medicine and Early Development. The Sample Manager is responsible for study set-up in the analytical LIMS software for clinical trials and non-clinical studies based on defined standards in adherence with study timelines.

Key Responsibilities:

  • Key partner for the clinical operations teams, bioanalytical experts, and outsourcing departments.

  • He/she manages the studies in the analytical software in compliance with the standards to support flawless conduct of clinical trials.

  • He/she is an expert in management of clinical samples including, but not limited to, pharmacokinetic (PK), anti-drug antibodies (ADA), anti-drug conjugates (ADC) and biomarkers (BM).

  • He/she will be responsible for interfacing with a new biorepository system for tracking samples and with information systems associated with Central Laboratories and/or specialized sample tracking providers.

Basic Qualifications:

  • Expertise in Laboratory Information Management Systems (e.g., Watson LIMS) for sample handling, tracking, and sample storage.

  • Excellent knowledge of clinical development.

  • Proficient in English (written and verbal).

  • Basic knowledge of bioanalytical methods.

  • Basic understanding of biomarkers.

  • Basic knowledge of oncology and/or rare disease clinical trials.

  • Creating a sample management plan for each study.

  • Demonstrates high motivation for the job.

  • Self-motivated and interested working in a complex environment.

  • Ability to handle multiple tasks and prioritize effectively, detail oriented and highly accurate.

  • Experience working in a regulated environment according to GLP/GCLP/CAP/CLIA standards.

  • Anticipates complex problems and proactively works to minimize their impact.

  • Very good organizational skills.

  • Strong interpersonal and communication skills, interfacing with cooperating departments and external partners.

  • Team player keen on receiving and sharing knowledge/expertise in a global team.

  • Ability to train and coach new Sample Managers and Sample Coordinators in study set-up, sample handling processes and relevant documentation.

  • Experience in sample reconciliation to investigate and resolve samples discrepancies between the bioanalytical lab/LIMS and the clinical database.

  • Knowledge of CDISC and controlled/standard terminology usage.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

#LI-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Keywords: Principia Biopharma Inc., Framingham , Sample Manager, Other , Framingham, Massachusetts

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