Biomarker Study Operations Manager

Employment Type

: Full-Time

Industry

: Miscellaneous



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The Biomarker Study Manager will operationalize and manage clinical study support across multiple drug development programs. 

The Biomarker Study Manager will be part of the Translational Research- Biomarker Discovery and Development team. They will work closely with the scientists/biomarker leads in the functional unit, clinical operations lead with client, and with external contract research organizations (CROs) to enable implementation of biomarker and immunogenicity assays. 

The Biomarker Study Manager will be responsible for managing the number of clinical studies across the client’s portfolio, plan timelines, and oversee the execution of assays and deliverables from CROs in a timely manner.

In this role, the Biomarker Study Manager will also interface with strategic sourcing group and compliance functions within BP to ensure appropriate contracts are in place and CROs qualified for performing GLP, GCP and GCLP work in support of clinical studies.

In consultation with Biomarker leads, the Biomarker Study Manager may review and provide input into clinical protocols, ICFs, generate sample collection protocols, provide input into lab manuals, etc.

The Biomarker Study Manager will also be responsible for ensuring the appropriate storage or disposal of clinical samples and setting up sample management/repository with external partners.

Roles and Responsibilities

  • In collaboration with biomarker leads and clinical study teams/operations leads, drive the implementation of necessary biomarker and clinical immunogenicity assays at external contract research organizations (CROs).
  • Plan and perform all operational activities starting with transferring material, reagents to CRO labs, plan and manage timelines related to assay validations, and study sample analysis in collaboration with biomarker study leads. Plan and ensure appropriate data and report delivery upon study sample analysis
  • Review and provide necessary input into sample collection protocols, ICF, and other study-related documentation. 
  • In consultation with biomarker study leads, set up, and manage regular meetings with CROs. As necessary initiate new work with CROs by interfacing with strategic sourcing group and ensure the qualification of new CRO labs by working with BP compliance leads.
  • Set up and manage processes for storage or disposal of clinical and preclinical samples by working with external partners
  • Provide operational support of initiation and management of preclinical and translational studies with external partners/CROs
  • May review validation reports, bioanalytical reports, perform data analysis and provide feedback as necessary
  • Qualifications:

  • At least a master’s degree in Biology/biochemistry/immunology or related field with 5 years of relevant experience or a BS degree in a related field, with 10 years of relevant experience.
  • Previous experience in Pharma/Biotech or CRO settings supporting biomarker and bioanalytical assays using a variety of technologies.
  • Experienced in implementing assays in the laboratories, understanding of elements required for clinical study support required.

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