Company:  Confidential

Job Title: Biosamples Manager

Job Number: 74418

Location: Boston, US

Job Description

This role involves supporting various clinical trials, including external collaborators, biorepositories, laboratories, and CROs. You will collaborate across functions to ensure the successful implementation, compliance, and support of clinical biosample plans and management for clinical trials.


* Execute biomarker strategies for supporting the clinical development of compounds.  * Assist in the review of biomarker-related content in various clinical study documents such as study protocols, laboratory manuals, study tools, and site-facing training materials * implement functional requirements for establishing central laboratories and configuring laboratory collection kits. * Oversee biomarker sample management and biosample tracking functions to support teams managing clinical studies. * Contribute to the implementation of biomarker collection and analyses, ensuring compliance with sponsor processes and local regulations. * Collaborate with clinical sites to guarantee timely and accurate biosample collection in alignment with study biomarker plans. * Generate biomarker data deliverables in collaboration with research, translational, statistics, and clinical science team members.

Required Skills

* Bachelor’s degree in life sciences. * 5+ years of clinical research experience. * Biotech or pharmaceutical sponsor experience highly preferred. * Experience working with third party central laboratory vendors. * Familiarity with LIMS databases and biosample tracking tools. * Solid understanding of good clinical practice (GCP/ICH) and good clinical laboratory practice (GCLP)

Application Deadline: 2024-03-18


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