Manager / Sr. Manager of Clinical Biosample Operations

5 - 7 years experience  • 

$100K - $130K
Posted on 05/24/18 by Lindsey Summers
Watertown, MA
5 - 7 years experience
$100K - $130K
Posted on 05/24/18 Lindsey Summers

Manager/Sr. Manager of Clinical Biosample Operations

Watertown, MA

Responsibilities:

  • Will lead efforts to define and evaluate technologies for implementation of the biomarker strategy in support of clinical development
  • Provide support to the clinical team driving agreed upon biomarker sample management for the clinical projects
  • Leads biomarker plan development and provide detailed information into the decision-making process of defining clinical biomarkers for clinical studies
  • Leads lab manual generation with selected central lab/biomarker provider
  • Serves as a point of contact for the biomarker and all clinical sample operations, including our central lab, specialty lab, and clinical kit manufacturer
  • Coordinates sample operations to ensure that clinical samples are tracked, and information deriving from samples is obtainable from our vendors
  • Supports the review of the biomarker sections of the clinical protocol, study/lab manuals and consent forms
  • Works with clinical sites, as needed, to ensure accurate and appropriate sample collection to support the biomarker strategy
  • Supports the analyses of biomarker data, collaborating with biostatisticians, bioinformatics, clinical and research colleagues internally and externally
  • Develops and provide ongoing sample training to team members
  • Supports teams to ensure bio samples are compliant with informed consent and GCP/ICH
  • May participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data reporting
  • Collaborates with individuals from Research, Clinical Development and Clinical Operations

Requirements:

  • BS required; in a science-based field; Advanced degreepreferred
  • 5+ years of clinical research experience which must include sponsor experience
  • Direct experience with clinical sample management and external vendors required
  • Experience with oncology, drug development, immune therapies and/or biologics preferred
  • Prior process development experience needed
  • Familiarity with databases is essential
  • Understanding of good Clinical GCP/ICH is required
  • Demonstrates effective communication skills and attention to detail
  • Ability to work collaboratively in a fast-paced environment
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