Company: Principia Biopharma Inc.
Posted on: June 7, 2021
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 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
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.
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
Creating a sample management plan for each study.
Demonstrates high motivation for the job.
Self-motivated and interested working in a complex
Ability to handle multiple tasks and prioritize effectively,
detail oriented and highly accurate.
Experience working in a regulated environment according to
Anticipates complex problems and proactively works to minimize
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
Experience in sample reconciliation to investigate and resolve
samples discrepancies between the bioanalytical lab/LIMS and the
- Knowledge of CDISC and controlled/standard terminology
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.
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
Keywords: Principia Biopharma Inc., Framingham , Sample Manager, Other , Framingham, Massachusetts
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