Location:
US East Coast

Job Summary

Role summary The purpose of this key role is to provide leadership and line management to a team of Clinical Site Managers (CSMs) within the Clinical Operations team and to develop and maintain strong sponsor relationships with participating US sites, in order to drive optimal site performance You will be responsible for the performance of trial sites in US in compliance with Good Clinical Practice, ICH guidelines and all applicable regulatory requirements. This includes site identification, qualification, selection, initiation, monitoring and closeout. You will perform co-monitoring and Accompanied Site Visits to provide oversight of CSM and site performance You will contribute to trial site documents and tools with ongoing reporting responsibilities for progress of recruitment including document management. You will also act as primary liaison between sites, CSMs and relevant functions to enable Autolus clinical trials to be delivered to quality, budget and milestones. You will develop direct relationships with US sites to ensure site performance and delivery is optimized. You will have on-boarding (including oversight of comprehensive training e.g. on internal tools, Sharepoint), management, mentoring and training responsibilities for CSMs. In addition, you will also collaborate with functional team members from various Autolus departments to support data quality management and reporting. Some additional Monitoring support may be required and the oversight and site management of 1-2 active sites may be required. Key Responsibilities

• Manage a group of experienced field-based CSMs to meet Autolus site management and monitoring requirements
• Lead US CSM resourcing strategy and oversight, ensuring appropriate workload across CSM team
• Lead Site Management Meetings and escalate issues, where necessary
• Recruitment, on-boarding and management of the CSM team ensuring individuals are appropriately trained and have the required capabilities to perform their duties to the highest standard for all Autolus studies. Ensure CSMs receive and understand ongoing training, including project specific, procedures, systems and tools
• Ensure CSMs perform monitoring and site management responsibilities to a high working standard including (but not limited to ): completing site visit reports and follow-up letters in a timely manner; managing investigational product; completing source data verification; optimizing site-level patient recruitment/retention and developing effective relationships with sites
• Ensuring site qualification, initiation, monitoring and study closeout visits are conducted in accordance with relevant regulatory regulations, Good Clinical Practices, GxP, ICH Guidelines, and Standard Operating Procedures and business processes
• Review and support sign off of Monitoring Visit Reports with a focus on Protocol Deviations and trends across the US Sites.
• Tracking and reporting of data cleaning status, providing oversight to ensure delivery to data cleaning targets as set by the Clinical Study Team
• Act as Autolus ambassador with external customers / participating sites to ensure consistency and harmonisation of monitoring activities, along with the identification and development of key accounts, building those relations that are pivotal in meeting and driving the business need; Act as a point of contact / escalation as required
• Maintain and optimize monitoring processes to meet regulatory requirements and industry best-practice
• Providing oversight of the entire site management process for the life cycle of the trial sites, eTMF management, development and maintenance of trial documents, including tracking of site performance metrics
• Monitoring activities of assigned sites and as primary liaison for all clinical monitoring issues, escalating as appropriate to Project Manager and / or Functional Manager in accordance with relevant study plans and Standard Operating Procedures and business processes
• Collaborating with CSMs to develop corrective plans relating to non-compliance at site
• Assist CSMs with the preparation for audits and inspections, including file review according to the clinical project plan
• Review and appropriate management of protocol deviations in collaboration with the CPM and CSMs and escalating as required
• Developing and maintaining a country recruitment / long term retention strategy in collaboration with the Clinical Project Manager (CPM) and Clinical Programme Lead (CPL)
• Identifying potential risks /mitigations to the enrolment targets and study conduct based on feasibility and recruitment updates in collaboration with the CPM and CPL
• Attending, participating and presenting at Investigator meetings as needed
• Supporting the Clinical Project Manager, Data Manager, Pharmacovigilance and Medical Monitor in communicating and resolving issues and obtaining follow-up information
• Liaising with key departments as required, maintaining timely and effective communication
• Ability to travel to US sites to maintain contact and support site relationships , carry out monitoring, co-monitoring and Accompanied Site Visits.
• Contribute to the evaluation and implementation of technologies and processes to support site management activities
• Any other duties as required following consultation with the post holder