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Biosample Operations Manager
Ref No.: 18-04254
Location: Cambridge, Massachusetts
Start Date: 04/16/2018
The client is seeking a Biosample Operations Manager to support the clinical teams and to work across its projects as well as with the external biorepositories, assay laboratories and CROs. This position may report directly to the client's Head of Therapeutic Operations or to a Clinical Biomarker Director. This position will work collaboratively across all therapeutic area teams to ensure implementation, compliance and support of biosample management for clinical trials conducted by the client.
  • In collaboration with individuals from Clinical Biomarker Director and Research groups to support the evaluation of technologies to identify, define and implement the biomarker strategy to support the clinical development of the client's compounds
  • Provide support to the clinical teams driving agreed upon biomarker sample management for the clinical projects.
  • Support the review of the biomarker sections of the clinical protocol, study/lab manuals and consent forms
  • Build cross functional process for sample flow, biorepository usage
  • Develop and provide ongoing sample training to team members
  • May participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data reporting
  • Work with clinical sites, as needed, to ensure accurate and appropriate sample collection to support the biomarker strategy
  • Serve as a point of contact for the biomarker sample repository
  • Support the Clinical Biomarker Directors in the analyses of biomarker data, collaborating with biostatisticians, bioinformatics, clinical and research team members
  • Support teams to ensure biosamples are compliant with informed consent and GCP/ICH
Qualifications
  • Bachelor's degree in a science-based subject; Advanced degree preferred
  • Minimum of 5 years of clinical research experience which must include sponsor experience
  • Direct experience with clinical sample management
  • Prior process development experience needed
  • Familiarity with databases is essential
  • Solid understanding of good Clinical GCP/ICH is required.
  • Strong communication skills and attention to detail