Sr. Project Specialist (Czechia)

<p>At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.</p><p></p><p>We are looking for a Sr. Project Specialist (SrPS) to join our A-team (hybrid*/remote). As a SrPS at Allucent, you serve as a key role in project administration to deliver projects within the established budget and timeline in collaboration with Clinical Project Management. The SrPS provides support to project management by overseeing and handling global administrative tasks in accordance with the scope of work. </p><p></p><p><strong>In this role your key tasks will include:</strong></p><ul> <li>Create and/or maintain tracking tools for clinical data management</li> <li>Enter data into systems and tools per required processes</li> <li>Review reports in applicable systems to ensure completeness, consistency and information is up to date prior to their distribution </li> <li>Coordinate, prepare, handle and distribute clinical trial support materials if done centrally</li> <li>Support with the preparation of the study-related presentation materials (Kick off Meeting, CRA Training and Investigator Meeting, regular and ad hoc meetings) and present as needed</li> <li>Support in creation of Project Plan and other study plans including templates</li> <li>Attend handover meetings for the CTAs who are joining/leaving the study. Review handover form and act as Transfer Chair, if delegated by the Line Manager of the Leaver or Replacement</li> <li>Support PMs during audits/inspections. Ensure follow-up on open action item for resolution within given timelines</li> <li>Responsible for vendor management, as needed</li> <li>Support Clients with ad hoc requests</li> <li>Process subject registration on slot reservation protocols</li> <li>Within the scope of assigned responsibilities resolve study related problems, anticipate risks and offer action plans to avoid critical situations and provide clear guidance to the study team </li> <li>Facilitate team communication and liaise with sponsors, sites and third parties </li> <li>Prepare Study Correspondence Management Plan (SCMP)</li> <li>Process Public Folders (PF) for study level as per SCMP Ensure study PFs are maintained by the trial team to accomplish inspection readiness</li> <li>Coordinate internal and external project team conference calls, process agendas, meeting minutes, and action log or equivalent </li> <li>Chair/lead teleconferences as needed</li> <li>Adapt default folders on SharePoint</li> <li>Support TMF Lead (TMFL) with the setup of Trial Master File (TMF)</li> <li>As a document owner, is responsible for document filing on trial level, and can act as a document submitter for other document owners on trial level as needed</li> <li>Work with TMFL on reconciliation of TMF trial level documents</li> <li>Coordinate and support the project team with the periodic review of study files for accuracy, quality and completeness, including tracking of the outstanding issues for proper resolution </li> <li>Coordinate and support the project team with the final reconciliation and off-site archival of project documentation </li> <li>Provide clear guidance to CRAs/ CTAs and coordinate setup of investigator site files</li> <li>Customize and distribute study logs/forms/templates</li> <li>With the PM, ensure all activities included in the project scope of work are completed and project timelines are met </li> <li>If delegated by PM/CTL, enter trial level data in CTMS and conduct monthly reviews to ensure that content is accurate and up to date. Follow up with local study teams to ensure country and site level data is being updated regularly in CTMS. </li> <li>Support PMs with budget related activities, as needed</li> <li>Create Contracted FTE by Month files </li> <li>Administrative support for Trial Committees activities for assigned studies</li> <li>Actively support to staff learning &amp; development within the company</li> <li>Mentor and help with on-boarding of new PS</li> <li>Draft and contribute as Subject Matter Expert (SME) in the field of PS activities to the evaluation/improvement of processes and procedures within the Quality Management System</li> <li>Assure good communication and relationships with (future) clients</li> <li>May contribute and take part in client evaluations, visits and bid defenses</li> </ul><p><strong>Requirements</strong></p><ul> <li>Life science, healthcare and/or business degree preferred; High School Diploma/Certificate or equivalent combination of education, training and experience; </li> <li>Minimum 2 years of Project Specialist II work experience for internal candidates</li> <li>Minimum 4 years of experience in drug development and/or clinical research for external candidates</li> <li>Good/ knowledge of GxP (standards of good practice)</li> <li>GDPR and applicable regulatory requirements</li> <li>Strong written and verb