• EN

Bioanalytical Study Manager

Boston Minimum 3 years becholer degree
  1. The candidate will support all aspects of bioanalytical vendor management activities to develop, validate and execute bioanalytical method development and subsequent routine bioanalysis to regulatory requirements
  2. Collaborate with Project Teams and other functional groups, including internal clinical development teams and external clinical sites to define and implement bioanalytical support for team objectives
  3. Manage bioanalytical CROs to maintain timelines and data quality in support of bioanalytical work for clinical phase studies
  4. Maintain vendor relationships and readiness through regular interactions, correspondence, and site visits (where appropriate)
  5. In collaboration with Clinical Operations team, manage tracking, logistics, primary record keeping and sample quality of bioanalysis samples.
  6. Prepare and review key study start up documents such as clinical study protocols, clinical kit development, lab manuals and consent forms, and to verify that biological samples are collected as specified in the protocol and related plans.
  7. Promote and develop process improvements for clinical sample lifecycle management including specimen collection, tracking and downstream storage and/or destruction.
Qualifications and experience:
  1. BS or higher in scientific discipline required. Minimum 3 years of related experience required; direct clinical operational experience, with exposure spanning initiation through study completion preferred
  2. Experienced in Bioanalytical expertise and in a regulated bioanalytical sciences environment
  3. Familiarity with relevant bioanalytical regulations and guidance including GLP, FDA, EMA, ICH
  4. Collaboratively work in a cross-functional team and fast paced-environment as well as ability to interact with various levels within the organization and external vendors
  5. Strong organizational and communication skills is essential
  6. Demonstrated ability to work independently and to multitask
  7. Work on site in Boston MA
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