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Senior Manager Patient Scheduler and Logistics
1 month ago
Role Summary
- The Senior Manager Patient Scheduler and Logistics will execute as well as manage a team responsible for the coordination and scheduling of patients and their cells (apheresis & final drug product), through the clinical/treatment site. This requires close collaboration between the Investigator Site, Couriers, and internal functions in Autolus including Manufacturing, Supply Chain, Clinical Operations and Medical to ensure that each patient visit and their CAR T-cells are coordinated seamlessly and effectively through their cell journey. The post holdermust ensure she/he and their team meetthe required timelines and the needs of the patient, clinical trial and manufacturing in a rapidly changing environment.
- The Senior Manager Patient Scheduler and Logistics will function as part of the Patient, Cell and Logistics Management (PCLM) team within Product Delivery and Operations. She/he will establish functional team goals as well as develop, manage and lead their team.
- As a manager of people, the role requires conflicts and issues are promptly and effectively resolved. Providing guidance, feedback and ensuring team members have the resources to meet goals is essential in leading high performing team. Key Responsibilities • Act asthe interface and lead between clinicaltrialsites, clinicalstudy team,manufacturing and clinical operations to ensure smooth scheduling and coordination of both patients and cells within and across EU/US clinical trial sites. • Identify and resolve issues or barriers which impact scheduling and coordination execution Coordinate and or manage patientscheduling and cell management tasks from:
- o Initial patient identification
- o Patient consent and screening
- o Confirming apheresis and subsequent despatch to manufacturing o Coordinating Courier pick-ups and deliveries as well as pre-alerts
- o Confirming to Clinical Site successful product manufacturing & coordinating patient visits preparation prior to infusion (chemotherapy conditioning)
- o CAR T-cell Drug Order form to clinical trial site & confirming receipt by clinical site o Review documents prior to site shipments o Coordinating of the final drug product (CAR t-cell) to the investigator site and successful product infusion to the patient
- Maintain the patient confidentiality and adheresto allrelevantData Protection requirements.
- Use relevant tools and communication with clinical sites, optimise patient and drug scheduling, to optimise the number of patients recruited per site per month/year.
- Assist peers and colleagues in understanding, supporting and executing cell journey processes.
- Communicate study requirements to the clinical sites, while ensuring adherence to the cell journey process.
- Lead initiatives which continuously refine and improves the cell journey process including the screening/enrolment of trial patients, patient scheduling and treatment process.
- Establishes team strategy and goals. Charts course, determines obtains resources and leads team to achieve goals.
- Actively manages and leads team in reaching department and individual development goals.
- Provides timely, constructive and actionable feedback as well as supports, motivates and energizes team members to perform to their potential. • Defines metrics to drive performance and reach goals. Analyse metrics to make decisions, take action, inform management etc.
- Proactively identifies potential study issues/risks and recommends/implements solutions. • Work with multiple internal and external stakeholders, including vendors, to communicate detailed timelines and ensures performance expectations are met.
- Act as a functional expert for the "Cell Management Portal".
- Responsible forthe implementation/deployment of Autolus Cell/Drug Handling manual atthe investigator site, including oversight of completed up-to-date training of relevant personnel.
- Ensure compliance to GxP including ICH GCP guidelines and regulations across the Investigator sites and ensures Autolus 'Inspection Readiness' at all times.
- Participate and or lead the development, review and implementation of departmental SOPs and processes.
- Attend internal and external team meetings, as scheduled and necessary.
- Travel up to 25% of working time to EU and US sites.
