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About the role

This role will be responsible for ensuring robust and efficient sample shipment, sample testing and data reporting. You will report to the Director of Vendor Oversight and BioSample Operations Manager, and be a member of the Translational Science group. You will play an essential role in organizing complex clinical sample management processes across multiple clinical programs. Areas of responsibility include working cross-functional within Sana groups (Clinical Operations, Clinical Data Management, Translational Sciences Bioassay Teams) to ensure bioassay deliverables with testing labs and the Central Lab. This includes sample management, query resolution, and setting up data transfers from CROs to Sana Data Management to ensure data deliverables are met. You will work to align sample management activities with individual program and corporate goals. Cool stuff.

What you’ll do

• Be a point of contact for operational activities relating to clinical sample management plans in order to deliver quality samples and data used in clinical studies
• Serve as a contact between clinical study team, CRO, central and testing labs for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and data reporting
• Interface and collaborate with Clinical operations, Biomarker lead, Central lab, specialty labs, other Sana functions as necessary and CRO to generate the Lab Manual and Flow Chart.
• Support Sana Data Management on generation of assay data transfer documents.
• Manage end-to-end patient sample management, from site collection through analysis and final disposition
• Support and assist the tracking of budget and timelines for clinical testing labs
• Identify sample discrepancies and missing samples, request queries, track queries and assist in query resolution and notify key stakeholders
• Maintain sample and data repository. Support sample analysis data transfer, data reconciliation and data review
• Assist with the data handling/archiving at the completion of the study and coordinating archiving of clinical samples with all groups at Sana collecting clinical samples
• Work with clinical team to review and set up clinical documents.
• Help create efficient sample flow in partnership with all departments collecting clinical samples at Sana

What we’re looking for

• Bachelor's is required, an advanced degree a plus. 3+ years of related experience with previous clinical biosample management and clinical laboratory vendor management is preferred
• Strong organizational skills with attention to details. Independently manage multiple competing priorities, while working on multiple projects simultaneously
• Great communication skills
• Ability to simplify complex processes
• Ability to work across multiple departments
• Knowledge and proficiency in FDA & ICH/GCP regulations and guidelines

What will separate you from the crowd

• Previous cell and/or gene therapy experience
• Previous and proving ability to work with Clinical teams and Clinical trial sites

What you should know

• Occasional travel required
• The base pay range for this position at commencement of employment is expected to be between $125,000 and $145,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together

• Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
• Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
• Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’s Benefits Portal.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.