Senior Biosample Operations Manager (Onsite)

SUMMARY/JOB PURPOSE:

The Senior Biosample Operations Manager (BOM) provides biosample management expertise to the study management team and ensures that biosamples collected are of optimal quality and adhere to the highest standards. Working closely with scientists, the BOM plans and coordinates operational activities for the collection, handling, storage, delivery , and life cycle management of pharmacokinetic, immunogenicity, pharmacogenetic, and biomarker samples and associated data for multiple clinical studies across all phases.  The BOM is accountable for developing and adhering to testing and data delivery timelines for both study and program deliverables.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage the development, preparation, and update of study and program-related documents, including a biosample management plan, laboratory manual, lab requirements, sample handling requirements, and SIV/monitor training materials in collaboration with lead scientists, and central and analytical laboratories.

• Facilitate set up of Central Lab for research samples, including sample collection and processing instructions, kit contents, shipping conditions/schedules, and logistics. Driving updates related to changing protocol or study needs.

• Manage sample transfers with Central Lab, testing labs, and sample archive. Facilitate resolution of issues.

• Manage and monitor timelines for sample delivery, testing, and data transfer for analysis at both internal labs and external vendors. Coordinating timelines and communication between functional areas.

• Support data transfer and discrepancy resolution processes, coordinating resolutions to meet study timelines.

• Manage and monitor Translational Sciences program deliverables to support regulatory filings

• Compile and report sample and testing metrics to the study team.

• Track deliverables to closure and monitor filing to the appropriate repository.

• Provide input on Protocol/ICF development and support the study team with responses to IRB/EC questions.

• Responsible for training investigational sites and study monitors on biosample requirements.

• Participate in design and UAT of study eCRF and reconciliation tools.

• Develop processes, tools, procedures, and reports to support the Biosamples Operations function

• May support internal sample management processes and activities.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in a related discipline and a minimum of 9 years of related experience; or,

• MS/MBA/MA in related discipline and a minimum of 7 years of related experience; or,

• PhD in a related discipline and a minimum of 2 years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Prior experience in managing samples for clinical development studies

• Strong experience in GCP/GLP/CLIA regulated environment

Knowledge/Skills:

• Proven clinical development experience working in clinical study teams or monitoring clinical studies.

• Strong background in clinical sample collection, logistics, and operations.

• Working knowledge of bioanalytical or clinical laboratory.

• Experience in GCP/GLP regulated environment.

• Strong verbal, written, and presentation skills.

• Proven ability to successfully plan, organize, and proactively manage multiple projects and effectively prioritize.

• Ability to work effectively across functions in a matrixed environment and effectively interact with a wide variety of internal and external stakeholders at all levels of the organization.

• Proven critical reasoning skills, including the identification and resolution of complex problems.

• Strong attention to detail (strive for error-free results).

• Thoughtfully apply feedback to improve systems, skills, and deliverables.

• Strong proficiency in software applications related to sample tracking. MS Excel competencies include the use of pivot tables and VLOOKUP.

JOB COMPLEXITY:

• Position is complex and operates with independence.  Errors in judgment could have a considerable impact on study deliverables.

WORKING CONDITIONS:

• Position is office-based and is onsite five days a week

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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