Duties: 

• Clinical Laboratory & Biospecimen Management (CLBM) is a group within Strategic Research and Development Operations (SRDO) that provides effective and efficient vendor oversight (operational, contractual, and financial) for Central and Specialty Laboratories involved in all stages of company’s clinical trials. 

CLBM is organized to focus on both Biospecimen Management and Vendor Operations with dedicated resources for:  

• Biospecimen Management.
• ECD/Study Start-Up.
• LCD/Study Maintenance & Close-Out.
• Ultimately, CLBM ensures the ethical collection, analysis, and lifecycle tracking of human biospecimens to deliver timely data in support of clinical protocol timelines.  
• The Senior Vendor Laboratory Manager (SVLM) is a critical senior member of CLBM. 
• In addition to the key responsibilities of the VLM, the SVLM will concentrate efforts in study maintenance and close-out to ensure that clinical timelines/deliverables are met to support the lifecycle of the clinical trial. 
• The SVLM will employ operational and logistical strategies ensuring the execution of study deliverables with quality and efficiency, on time, within budget and meets intended use. 
• The senior manager achieves these objectives leveraging scientific expertise, strategic thinking, a global mindset, and cross functional collaboration.
• 7+ years project management, and/or clinical operations experience.

Key Responsibilities:

• Serve as VLM for one program or select studies as necessary. Independently perform all key responsibilities of VLM. 
• Participate, as needed, in the selection of central and specialty lab vendors. 
• Key contributor to study start-up activities and clinical timeline management and contract modeling as needed.
• Partner with Global Study Operations, Business Operations, Data Management Sciences, and Translational Sciences to lead lab vendor/biospecimen close-out activities and ensure that vendor/study deliverables are completed. 
• Understanding of the regulatory environment, relevant changes, and their impact on study design, execution, and biospecimen-related processes.
• Define scope of work and understand intended use for clinical lab and biomarker assays as defined by the clinical protocol and including study protocol objectives.
• Understand assay “intended use” and regulatory requirements, to ensure the right vendor/assay combination is selected for the clinical program as needed.
• Perform financial and contractual review in support of ECD and/or LCD studies. 
• Identify, track, troubleshoot, and solve operational issues at the vendor in partnership with the clinical or translational sciences teams.
• Address any operational questions that arise and resolve or triage to the appropriate individual or cross-functional group.
• Review informed consents and its impact on biospecimen management. 
• Triage and resolve questions from health authorities and regulatory bodies specific to consent and biospecimen management.
• Review of contracts and financial oversight of ECD and/or LCD programs for alignment with LOS forecast including modeling, invoices and accruals.
• Provide training and mentorship to manager level staff.
• Actively participate in and contribute to higher level cross-functional conversations (i.e., CLS, Data Science, Central and Specialty Lab Strategy).
• Manage complex clinical trial protocols and/or vendor relationships.
• Balance multiple priorities in a fast-paced, team-based environment.
• Review Sr. Leadership Top-Line updates and ensure that CLBM deliverables are accurate and on track.
• Perform steward duties for research requests for biorepository specimens and data analysis, if needed.
• Be the point of contact with research colleagues that have questions about availability and suitability for future research use of residual clinical biospecimens. 
• Has a strong scientific background in a relevant field to appreciate biomarker discovery research topics that are relevant to review for future research. 
• Participate in inquiries related to the appropriateness or integrity of biospecimens, work with CLBM Stewards on disposal requests as appropriate.
• Actively contributes to cross-functional team definition of goals, roles and tasks.
• Other duties related to CLBM remit as assigned.

Education: 

• PhD Degree with life sciences/laboratory background, including biomarkers and 2+ years project management, and/or clinical operations experience.
• Master's Degree with life sciences/laboratory background, including biomarkers and 5+ years project management, and/or clinical operations experience.
• Bachelor's Degree with life sciences/laboratory background, including biomarkers and 7+ years project management, and/or clinical operations experience.
• Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples. 
• Working knowledge of human biospecimen sample types and associated storage/shipment conditions.
• Relevant professional experience working in the pharmaceutical/biotechnology industry, clinical research setting or clinical/diagnostic/central or specialty laboratory which includes specimen management, biomarker operations, vendor management, translational sciences operations, clinical operations.
• Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP, In Vitro Diagnostic Regulation (IVDR) 2017/746, General Data Protection Regulation (GDPR), clinical laboratory specimen handling and able to determine a test's intended use.
• Planning, organizational and effective time management skills with an ability to adapt to changing priorities; excellent analytical and interpersonal skills.
• Very high attention to detail with the ability to work independently and manage multiple competing priorities.
• Critical reasoning skills including the identification and resolution of complex problems.
• Exceptional problem-solving skills required.
• Strong understanding and experience with risk identification, mitigation planning, management and execution.
• Strong understanding and experience with issue resolution.

The hiring range for this position is $61 to $71 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

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