Biosample Manager

During the first year, your goals will include:

• Planning, organization, and oversight of the entire lifecycle of clinical samples through collection, shipping, processing, storage and subsequent delivery for processing and analysis.
• Maintain oversight of all study biosample operational activities, including sample reconciliation, sample metrics and reporting.
• Develop study-specific sample management plans, including vendor agreements, site training materials, and engagement with site personnel performing sample collection, processing, and shipping.
• Develop timelines and all internal resource needs for all biosample operational activities, ensure proper study plans and tracking.
• Lead interactive data visualizations and analytical tools for reporting metrics and trends and data QC and identify and communicate critical trends to study teams.
• Participate in the identification, selection and oversight of laboratory vendors including drafting RFPs and defining scope of work in support of study objectives and goals.
• Develop the strategy for a scalable sample storage, tracking and access.
• Support sample analysis, data transfer, data reconciliation, and data review.
• Provide study level updates to partners, clinical study teams and biomarker teams including sample collection, assay status and analysis updates.
• Act as point of escalation for vendor issues/CAPAs and actively participate in audits

We'd love to hear from you if you have:

• BA/BS is required. MS, or PhD in Clinical Research or a related subject area preferred.
• 3+ years industry experience in clinical research at a pharmaceutical, biotech or CRO.
• Proven record of success in a cross-functional team environment.
• Clinical research experience in industry, ideally in Neuroscience or Oncology.
• Experience with vendor and CRO management.
• Proficient with sample data reporting, running metrics and understanding the overall quality and stability of study samples. 2+ years of experience in leading biosample operational activities in large, complex, and multi-center clinical studies.
• Have direct experience in managing human clinical sample types, including tissue across multiple therapeutic areas.
• Manage lab vendors and handle bio-sample management activities across multiple clinical trials.
• Responsible for providing oversight shipment and receipt of biological samples from central lab and clinical sites to bioanalytical labs.
• Collaborate with study teams, biomarker scientists, data management teams and biomarker vendors to ensure project timelines for sample analysis and data transfer timelines are maintained. Will also support activities such as sample reconciliation and data transfer specification review and finalization.
• Prepare and provide oversight of bioanalytical and biomarker vendors oversight plans and ensure compliance and inspection readiness of bioanalytical laboratories, as governed by GLP/GCP regulation.
• Responsible for coordinating reviews and approvals of sample analysis plans and final bioanalytical reports.
• Accountable for reviewing and finalizing lab vendors’ contracts, scope of work, lab manual, as well as related study start-up activities.
• Working knowledge of ICH/GCP/GLP regulations and biosample management standard methodologies.
• Experienced with managing central lab and 3rd party lab contracts and change orders to align with program goals
• Proficient in contract negotiation, set up and execution with external vendors including Central Labs, CROs and 3rd party biomarker testing laboratories
• Ability to be agile and familiar with different functions including data management, clinical trial operations, clinical science, and biostatistics.