This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Role Summary The Clinical Project Associate will provide support to the Clinical Project Manager/ Clinical Programme Lead and related team members by performing generic clinical trial management procedures and tasks associated with the day to day running of clinical studies/programmes throughout the entire study lifecycle (start up, maintenance and close out); Ensure work is conducted in line with standard operating procedures, policies and good practices. This is a key Coordination role which links the oversight of the Project Management across Autolus Departments and Vendors to ensure that all Depts and Functions are clear on tasks and timelines within the various projects as well as maintaining the administrative aspects of the trials. Key Responsibilities To support the Clinical Project Manager in all areas of the study e.g. vendor management, country, site and patient management study set up through to close out. To maintain: study trackers and dashboards Project Management Plan: to update the Project Plan with key dates and milestones as decided by the CPM/CST and various Depts. Working with the Accountable CPM to maintain Gannt charts and project timelines spreadsheets on an ongoing basis, particularly Monday.com Working closely with the CPM and across Departments (including Data Management). Under delegation by the CPM: input and maintenance of the Project Management Plan, Risk Management Plan Coordination transversally with different Depts in a matrix environment to enable successful and timely study execution Tracking of Study Metrics where applicable (time to set up, open queries etc) To set up, organize and maintain clinical study documentation files (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, periodic checks, final reconciliations and archiving. Responsible for version control and filing of documents within Sharepoint and the TMF. Accountable for TMF Contents Management Works with the CPM on the Contents of the ISF and also putting together the ISF during site set up Maintaining the study TMF to ensure that the TMF is complete and working closely with Vendors to ensure that their Checklists are up to date Supports the filing, maintenance, tracking and archiving of Trial Invoices Under delegation of the CPM Preparation of EC/IRB submission packages, preparation of Investigator Site Files and distribution study materials to sites. Responsible for agendas, Powerpoint slide(s) preparation and meeting (actions) minutes of the Clinical Study Team; alongside meetings with vendors and Investigators Review and QC of study documents e.g. ICF Coordination of translation of study documents e.g. ICFs Responsible for tracking invoices, and maintain PO oversight Regular communication with clinical trial vendors to contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, TMF management etc.) To take over responsibilities for certain specific areas of the project/vendors/mini projects of the clinical study as delegated by the CPM To serve as back-up for the CPM during absences To have individual ownership of specific tasks/Projects within the Project Management Team Understanding of regulatory and ethics processes and procedures in all sectors Flexibility to take on different organisational and administrative aspects of the trial Support the CSM Team (particularly with admin such as TMF filing and source doc management LI-DNI