Sanofi Group Supervisor, Biologic Sample Management & Data Management- Framingham, MA in Framingham, Massachusetts

Job Summary

The Sample Manager Supervisor is an expert and responsible for biological sample handling, ensuring the proper collection, storage and shipment of specimens of clinical and preclinical samples for R&D Translational Medicine and Development (TMED). The Supervisor BSM is responsible for study set up in the analytical LIMS software. The BSM ensures that studies are set up based on defined timelines and standards. The studies in the analytical LIMS software will be managed in compliance with the standards to fully support conduct of pre-clinical and clinical trials. In addition, the Supervisor is responsible for sample accessioning quality from a staff of 3 contractors working exclusively on Clinical Diagnostics.

Major Duties and Responsibilities

  • Management of 3 full time employees and 2-3 contractors for CDx sample accessioning.

  • Responsible for set up of clinical studies in the current bioanalytical LIMS system.

  • Ensure the correct storage and tracking of the Biological Samples in LIMS.

  • Maintains knowledge of current regulations related to the sample handling reconciliation and GCLP standards.

  • Interacts closely with CDx, PKDM-Leads, DMPK Expert, BcB-Leads Outsourcing Managers, CTOM/STM, TMED Business Operation France and SQO.

Clinical Trials Phase 1 to Phase 4

  • Clinical Team Member for TMED Ops in the Clinical Trial Team

  • Participates in relevant meetings for study setup and through the duration of clinical studies (e.g.: Kick-off meeting, CRA training, meetings with « Central Labs »)

  • Liaises directly with internal customers (BcB, Outsourcing, PKDM for assigned studies). Negotiates responsibilities and timelines.

  • Understand working processes and coordinates activities in conjunction with the study team OM, BcB-Lead.

  • Proposes solutions for sample handling management issues during the conduct of a study.

  • Review the documents related to the clinical trials(e.g.: Extended Synopsis, Protocol, Request For Proposal, CRF, Data Management Plan, Central Lab documents (Scope of Work), Lab Manual etc.…)

  • Responsible for preparation of relevant documents: CSP Appendix ,TMED Specifications, and other Sample Management Specific documents

  • Create studies in LIMS system (relevant software) for bioanalyses including printing Labels according to standards, if needed.

  • Manages electronic sample manifests files, as well as the creation and extraction of sample reconciliation and result files.

  • Delivers reconciliation files to the Data Management and solves discrepancies in close cooperation with the CTOM and the DM.

  • Participates in the training and prioritization of Sample Receiver activities such as receiving, shipping, biological samples storage and resolution of labeling errors.

  • In charge of study setup, in Watson LIMS, ensuring correct sample labelling and tracking

  • Working in regulated environment according to GLP/ GCLP and SOPs.

  • Participates in working groups or equivalent to develop, improve and adapt processes and procedures.

  • Trains other Sample Managers and Sample Receivers when necessary for business needs.

  • Serves as an expert for coaching new BSM in the areas of standards, study set up and design in the current bioanalytical LIMS system.

  • Maintains knowledge of current regulations and technologies related to the bioanalytical LIMS system.

  • Participates in working groups or equivalent to develop and implement new applications and procedures as needed.

Knowledge and skills

  • Expertise in LIMS Systems (e.g., Watson, Blaze, Nautilus) for sample handling and tracking storage.

  • Basic knowledge in basic bioanalytical methods

  • Excellent knowledge in the clinical development process

  • Anticipates complex problems and proactively works to minimize the impact. Delivers on commitments with high quality results.

  • Demonstrates high motivation for the job.

  • Ability to handle multiple tasks and detail oriented,

  • Ability to prioritize and adapt to change

  • Very good organizational skills.

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

  • Ability to train and coach new BSM in study set up, sample handling processes and relevant documentation.

Formal education and/or experience required

  • Bachelor degree, preferably in a life science or -related area (e.g. bioanalytical / computer sciences or similar technical field) or equivalent experience (at least 3 years) in bioanalytical areas.

Knowledge and skills desirable but not essential:

  • Knowledge of Sanofi SOPs

  • Experience working in a global team/environment

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.

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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life