Trial Master File Associate

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.Join Our Team as a Trial Master File Associate - home based in Italy, Israel or SpainAbout this roleAs part of our CDS Ophthalmology Trial Master File team you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.The Trial Master File Associate is part of the TMF Delivery Business Line within Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to organize, maintain and oversee the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional Lead and PM delegation.Key ResponsibilitiesNotify study team that TMF is created and ready for document upload for eTMF or submission to pTMFDevelop TMF PlanProvide training on study specific TMF requirements, guidelines including TMF PlanPerform QC2 on documents and documents reconciliationProvide TMF Monthly Reports to PM, Line manager and Head of TMF DeliveryRegularly check TMF metrics, follow up on detected issues, ensure acceptable level of metricsEnsure TMF processes timely implementation and executionAdjusting study specific TMF Index/EDL in the relevant files/s system as directed by the PM (Project Manager)Ensure valid forms and templates are implemented and maintained in the assigned projectsCheck status of duplicates, documents in error, size and path length (if applicable), follow up on necessary corrections accordinglyCoordinate Monthly and Quarterly TMF Reconciliation by creating Action Plan and submitting relevant report on the statusEnsure TMF AoR completion and monitoring TMF transfer/shipment to the SponsorEnsure delivery of fully executed TMF AoR to TMF Functional leadActively follow up that the study team is submitting documentation, EDL maintenance for eTMF in cooperation with study team, following the process described in The TMF Plan and that the TMF is always submission and inspection readyAct as contact person for study team to support on all TMF issues/inquiries independentlyIdentify general areas with missing documentation and inconsistencies and follow up with the study team for resolutionActively taking part in Study Team meetings and updates on the TMF statusAssist and attend activities associated to quality controls, audits and regulatory inspections in relation to the TMFIdentify TMF quality issues and elevate to the CRM/PM/Director, TMF Functional lead and collaborate in the action plans developmentResolve in cooperation with Study team all issue identified by Sponsor after TMF transferSet up the Investigator Site File (ISF)Actively contribute to the organization and development of routines to enhance the work at TFSDevelops and maintains an effective relationship with the study teamsOther, as identified by Line ManagerQualificationsAt least 1-5 year of experience in CRO or Pharmaceutical Industry with proven TMF Management.No less than 3 years of TMF experience (mandatory) with 1+ years of OPH experience (ideal)Bachelor's Degree in Health Science or Document Management or equivalent work experience is preferredKnowledge of GCP/ICH guidelinesGood written and communication skillsGood organizational and multi-tasking skillsGood software and computer skillsAble to work in a fast-paced environment with changing prioritiesTeamwork abilityEffective time managementWhat We OfferWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patientsA Bit More About UsOur journey began over 29 years ago in Sweden, in the city of Lund.As a full-service, global Contract Organization (CRO), we build solution-driven teams working towards a healthier future.Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization.They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction.By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence.This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.Together we make a difference.Trial Master File Associate • Metropolitan City of Milan, Lombardy, .IT#J-*****-Ljbffr