Sana Biotechnology
SeniorManager,PatientSupportOperations
“Senior Manager, Patient Support Operations at Sana Biotechnology. Skills: Patient Support Operations, Clinical Operations, Drug product logistics, Chain of custody. Own and manage clinical operational chain of custody. Partner with Technical Operations and Clinical Development stakeholders”
What You'll Achieve.
Ensure sites are fully equipped and prepared; Drive gap closure; Ensure execution aligns to program timelines; Ensure quality track milestones; Drive timely resolution; Ensure protocol compliance; Ensure patient safety; Ensure data integrity; Ensure accurate documentation; Improve playbooks
Industry & Context.
Problem-solving; Issue triage; Risk escalation; Risk mitigation; Complex problem solving
What They're Looking For.
Must Have
Bachelor's degree in life sciences or RN, 8+ years clinical development operations or CRA, Experience in transplant, apheresis, or cell therapy, Experience in cell therapy or transplant space, Surgical experience a plus, Comfort and proficiency in hospital/clinical setting, Ability to manage complex clinical logistics, Proven ability to ensure compliance with regulated chain of custody, Strong communication skills, Committed to quality, Proven track record of being thorough, Excels in organizational skills, Excels in time management skills
Nice to Have
Significant professional experience in transplant or cell therapy operations may be considered in exchange for a specific degree, Prior experience as an onsite representative of a sponsor or "Site Concierge"
What You'll Do.
Own and manage clinical operational chain of custody
Partner with Technical Operations and Clinical Development stakeholders
Refine and finalize hand-off procedures
Serve as primary site-facing single point of contact
Ensure sites are fully equipped and prepared
Proactively identify gaps
Collaborate with surgical and transplant teams
Provide real-time operational support
Provide technical guidance during dosing/transplant
Escalate time-critical risks
Coordinate between Technical Operations and clinical providers
Ensure execution aligns to program timelines
Ensure quality track milestones
Drive timely resolution
Onboard clinical sites
Manage clinical sites
Own readiness assessments
Own capability evaluations
Monitor ongoing operational performance
Implement corrective actions
Develop specialized playbooks
Maintain specialized playbooks
Continuously improve playbooks
Ensure controlled documentation
Ensure consistent implementation
Perform remote monitoring
Perform on-site monitoring
Provide site training
Provide site documentation
Provide site coordination
Oversee clinical trial conduct
Ensure protocol compliance
Ensure patient safety
Ensure data integrity
Ensure accurate documentation
Provide single point of contact
Provide operational guidance
Manage general triage of questions or issues
Handle communication pathways
Participate in regular study team meetings
Provide regular updates on site performance
Provide regular updates on execution
Support cross functional teams
Help develop consistent SOPs
Help develop Work Instructions
Support development of clinical site training playbooks
Support development of guidelines for Sana product delivery
Collaborate with CTMS development
Collaborate with CTMS maintenance
Collaborate with CTMS training
Collaborate with TMF development
Collaborate with TMF maintenance
Collaborate with TMF training
May be assigned Project Management tasks
May be assigned other operational tasks
May participate in audits
May participate in associated meetings
Perform preparation at study sites
Collaborate with study team members for project execution
Perform additional duties and tasks
How You'll Work.
Team & Collaboration
Clinical Development stakeholders; Technical Operations; Surgical teams; Transplant teams; Clinical providers; Study team members; Cross functional teams
Communication Scope
Technical outcomes communication; Executive presentations; Site performance updates
Process & Methodology
Project Management, Roadmap planning, Timeline management
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