Senior Manager, Biosample Operations
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<div><div><p style="margin: 12.0pt 0.0pt 6.0pt;"><span style="color: rgb(51,51,51);font-family: Aptos;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">Summary</span></p><p style="font-size: 12.0pt;line-height: 108.0%;margin: 0.0pt 0.0pt 8.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">The </span><span style="font-family: Aptos;font-size: 11.0pt;font-weight: bold;">Senior Manager, Biosample Operations </span><span style="font-family: Aptos;font-size: 11.0pt;">will</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">be responsible for planning, implementing, managing, and driving biological sample logistics across Phase I-IV Clinical Trials. This role is an essential member of the Clinical Operations function and must be able to collaborate with the cross-functional teams both internal and external.</span><span style="font-family: Aptos;font-size: 12.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">This position reports to the Head of </span><span style="font-family: Aptos;font-size: 11.0pt;">Biosample Operations, </span><span style="font-family: Aptos;font-size: 11.0pt;">Business Operations and Enablement, Clinical Operations. </span></p><p style="margin: 12.0pt 0.0pt 6.0pt;"><span style="color: rgb(51,51,51);font-family: Aptos;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">Responsibilities</span></p><ul style="margin: 0.0pt;padding-left: 0.0pt;"><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Expertly advise on and deliver the sample strategy for clinical trials within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Accountable for the implementation, execution and oversight of sample collection, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Independently review clinical study protocols, informed consents, laboratory documents, case report forms, laboratory scopes of work, laboratory budgets and invoices.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Review and file necessary vendor laboratory documents for the Trial Master File (TMF) as applicable. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of clinical trial samples. This includes but is not limited to oversight of sample collection at sites, shipment to vendor for processing/testing, sample queries and final sample disposition. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Be the primary point of contact for study team related to sample operations for assigned clinical trials. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Collaborate</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">with</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">cross-functional</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">study</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">teams</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">to ensure delivery of</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">samples</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">per</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">project milestones.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Track and report on sample management status and address issues proactively. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Lead innovation and process improvement activities for Biosample Operations and/or Clinical Operations functions. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Mentor junior Biosample Managers and Biosample Specialists. </span></li></ul><p style="margin: 12.0pt 0.0pt 6.0pt;"><span style="color: rgb(51,51,51);font-family: Aptos;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">Qualifications</span></p><ul style="margin: 0.0pt;padding-left: 0.0pt;"><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Bachelor’s degree, preferably in a scientific or healthcare field or equivalent combined education.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">7+ years of clinical trial management experience preferred.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">4+ years of Biosample Operations experience required.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Advanced understanding of clinical trial processes from study start-up through study closure related to sample collection, logistics, transit, storage, central tracking and global requirements.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Excellent knowledge</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">of ICH GCP</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">and GLP</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">guidelines.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Proven ability to independently establish priorities,</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">work with a strong</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">sense of urgency and collaborate (interpersonal, relationship management)</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">effectively</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">with the study team, cross-functional team members and external partners/vendors across multiple projects.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Advanced project management skills with the ability to identify risks and issues as well as propose appropriate measures as required. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners).</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Proficiency with Microsoft Office.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Excellent</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">verbal and written communication. </span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Proven problem solving and</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">decision-making</span><span style="font-family: Aptos;font-size: 11.0pt;"> </span><span style="font-family: Aptos;font-size: 11.0pt;">skills.</span></li><li style="background-color: rgb(255,255,255);font-family: serif;font-size: 10.0pt;margin: 5.0pt 0.0pt 5.0pt 45.25pt;padding-left: 9.5pt;text-indent: 0.0pt;"><span style="font-family: Aptos;font-size: 11.0pt;">Ability and willingness to travel ~10% (domestic/ international).</span></li></ul><div>This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $170,000 - $185,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. </div><div><br>Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets </div><div> </div><div>Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds. </div><h1><span style="font-family: Aptos;font-size: 11.0pt;">#LI-Remote</span></h1><p><span style="font-family: Aptos;font-size: 11.0pt;">#LI-JS1</span></p><p> </p><div><p style="margin: 0.0pt;text-align: center;"><span style="color: rgb(191,191,191);font-family: Aptos;font-size: 11.0pt;"> </span></p><p style="margin: 0.0pt;text-align: center;"><span style="color: rgb(191,191,191);font-family: Aptos;font-size: 11.0pt;"></span></p></div></div></div>