Job Description:

As a dedicated business unit of Théa, Sepul Bio is at the forefront of advancing transformative RNA therapies for hereditary retinal diseases, with a particular emphasis on the further development of two cutting-edge ophthalmic solutions"”Sepofarsen and Ultevursen. Sepofarsen targets Leber congenital amaurosis 10 (ACL10), a rare genetic ailment causing severe visual impairment, while Ultevursen is designed to halt vision loss in individuals with a mutation in exon 13 of the USH2A gene suffering from retinitis pigmentosa.Our mission, within the framework of Théa's established expertise, is to pioneer breakthroughs in the treatment of inherited retinal diseases, offering hope to individuals facing these challenging conditions. Through collaboration, specialized expertise, and unwavering dedication, Sepul Bio is committed to driving innovation in ophthalmic solutions and improving the lives of those affected by rare genetic eye disorders, particularly by further developing these two groundbreaking products. The CTC supports the clinical trials and the clinical operations team in managing various administrative tasks. The role involves providing essential administrative and operational support to ensure the successful execution of the clinical trials in accordance with ICH-GCP guidelines, regulatory standards and company policies. The CTC plays a key role in working cross functionally to support the clinical teams, including close collaboration with the teams from vendorsCROs in completing all required tasks to meet departmental and project goals. ResponsibilitiesExecution of all relevant tasks supporting the planning, execution and quality delivery of clinical trials in line with established targets and metrics. Support Clinical Trial Manager (CTM) and trial team with ad hoc activities.Responsible and accountable for tasks, processes and deliverables from trial start up through closure.Overseeing document management and filing of documents in the electronic Trial Master File (eTMF) to ensure inspection readiness. Set-up, maintain and close Sponsor eTMF (trial, country, sites) and ensure all relevant documents are filed in the correct way. Tasks include e.g. conduct eTMF spot-checks and follow-up on findings, quality review of the documents and eTMF, ensure completeness of the eTMF, support eTMF audits and inspections.Management of clinical trial documents and plans (e.g. coordinate document review, keep a list of documents including receipt and distribution, filing in eTMF).Attends and assists with the conduct of internal and external meetings and ensure timely communication to relevant stakeholders (e.g. emails, materials, agenda, invites, room booking), write meeting minutes and coordinate the review, filing of meeting documentation in the eTMF.Assist with the set-up and maintenance of study metrics trackers, tools and reports. E.g. clinical trial team member list, vendor list, trial team charter, trial document and plan list, protocol version log.Assist in obtaining Clinical Trial Insurance Certificates, e.g. obtain trial insurance certificates and policies before trial initiation, ensure trial documents are provide to the insurance broker, perform review of insurance documents and ongoing updates of insurances, yearly renewals, archiving of insurance document, maintain insurance log.Support with the handling, customization, review and finalization of CDA, clinical site contracts & budgets.Assist in establishing site budgets, tracking of investigator and third-party invoices and payments and budget reconciliation.Coordinate document translation with the CRO, if required. CompetenciesBachelor's degree or equivalent, preferably in life sciences or heath care.Clinical development experience within a pharmaceutical, biotechnology, CRO andor healthcare setting preferred.Understanding of medical terminology.Knowledge of ICH-GCP principles and regulatory requirements and the application of those principles to trial planning and conduct of clinical trials.Excellent computer skills (MS Office and clinical trial systems) and adaptability to new systems.Working knowledge of electronic trial master file (eTMF) management and clinical trial systems & portals.Excellent communications skills (verbal, written, presentation) in English.Service minded and demonstrated collaborative and stakeholder management skills.Strong attention to detail, result oriented, planning & organizing skills and the ability to prioritize and manage multiple tasks simultaneously.