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Senior Manager, Biosample Operations
Arcus BiosciencesSenior Manager overseeing biosample operations for clinical trials at Arcus Biosciences. Managing sample logistics, collaborating with cross-functional teams, and leading process innovations.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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.
- Accountable for the implementation, execution and oversight of sample collection, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality.
- Independently review clinical study protocols, informed consents, laboratory documents, case report forms, laboratory scopes of work, laboratory budgets and invoices.
- Review and file necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
- Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of clinical trial samples, including oversight of sample collection at sites, shipment to vendor for processing/testing, sample queries and final sample disposition.
- Be the primary point of contact for study team related to sample operations for assigned clinical trials.
- Collaborate with cross-functional study teams to ensure delivery of samples per project milestones.
- Track and report on sample management status and address issues proactively.
- Lead innovation and process improvement activities for Biosample Operations and/or Clinical Operations functions.
- Mentor junior Biosample Managers and Biosample Specialists.
Requirements
What you’ll need- Bachelor’s degree, preferably in a scientific or healthcare field or equivalent combined education.
- 7+ years of clinical trial management experience preferred.
- 4+ years of Biosample Operations experience required.
- 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.
- Excellent knowledge of ICH GCP and GLP guidelines.
- Proven ability to independently establish priorities, work with a strong sense of urgency and collaborate (interpersonal, relationship management) effectively with the study team, cross-functional team members and external partners/vendors across multiple projects.
- Advanced project management skills with the ability to identify risks and issues as well as propose appropriate measures as required.
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners).
- Proficiency with Microsoft Office.
- Excellent verbal and written communication.
- Proven problem solving and decision-making skills.
- Ability and willingness to travel ~10% (domestic/ international).
Benefits
Comp & perks- Remote work 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
ATS Keywords
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Hard Skills & Tools
clinical trial managementBiosample Operationssample collectionlogisticstransitstoragecentral trackingproject managementICH GCPGLP
Soft Skills
interpersonal skillsrelationship managementcollaborationnegotiation skillsverbal communicationwritten communicationproblem solvingdecision-makingprioritizationsense of urgency