Lavori attuali relativi a Trial Master File Associate - Lazio - Iriscube Reply
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Clinical Trial Associate
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Lazio, Italia Planet Pharma A tempo pienoPlanet Pharma is seeking a Clinical Trial Associate (CTA) to provide key operational and administrative support to a global Clinical team.This role plays an important part in maintaining quality systems, training compliance, documentation and clinical platforms, helping to ensure efficient and compliant clinical development activities.Key Responsibilities...
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Clinical Research Associate
1 settimana fa
Lazio, Italia Jobtome A tempo pienoA clinical research firm in Italy is seeking a Clinical Research Associate to manage recruitment for investigators and monitor clinical sites.The candidate will conduct submissions, ensure compliance, and act as a primary contact for regulations.Must have excellent knowledge of the clinical trial process and be fluent in English and Italian.The role offers...
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Senior Clinical Research Associate
14 ore fa
Lazio, Italia Advanced Clinical A tempo pienoSenior Clinical Research Associate (Oncology)Working embedded with a leading global oncology-focused biopharmaceutical companyWe are partnering with a top-tier global biopharmaceutical organisation to support a growing oncology portfolio and are seeking an experienced Clinical Research Associate to join the team in an advanced, hands-on clinical role.This...
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Lazio, Italia Bip A tempo pienoUna società di consulenza tecnologica in Italia cerca un Transfer Pricing Senior Associate per gestire progetti complessi di documentazione e fornire consulenze strategiche.I candidati ideali devono avere un Master in Economia, almeno 3-4 anni di esperienza pertinente e ottime capacità analitiche.È richiesta la conoscenza dell'inglese a livello...
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Lazio, Italia Advanced Clinical A tempo pienoA global biopharmaceutical company is seeking an experienced Senior Clinical Research Associate to join their oncology-focused team in Rome.This role involves conducting site monitoring visits, ensuring compliance with clinical trial guidelines, and supporting various aspects across the trial lifecycle, including feasibility assessments and patient...
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Study Project Manager
7 ore fa
Lazio, Italia Evidilya A tempo pienoEvidilya , the dedicated Contract Research Organization of Sprim Health Group operates as a full-service international expertise in successfully developing and managing observational, pre-clinical and clinical trials in the field of Food&Nutrition, Pharma and Medtech/Medical Devices industries with a strong technological and digital footprint, is looking for...
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Clinical Research Associate
7 ore fa
Lazio, Italia Translational Research In Oncology A tempo pienoOverviewIf you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!Translational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing translational cancer research in the clinical trial setting.Our passionate team is...
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Oncology Clinical Research Associate
14 ore fa
Lazio, Italia Translational Oncology Research, Llc A tempo pienoA clinical research organization dedicated to oncology is seeking a Clinical Research Associate to support its Monitoring Resources team.The ideal candidate will have experience with oncology trials, excellent communication skills, and a strong understanding of medical terminology.This home-based role in Italy requires a commitment to ensuring compliance...
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Etmf Specialist
7 ore fa
Lazio, Italia Iqvia Italia A tempo pienoOn behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for aeTMF Specialistwho can join an exciting working environment in a dynamic atmosphere.This position will...
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Clinical Research Associate
4 giorni fa
Lazio, Italia Ab Lavoro A tempo pienoDescrizione aziendaSiamo una società di consulenza, specializzata nella ricerca e selezione del personale, autorizzata dal Ministero ad operare come Agenzia per il Lavoro (Aut. Min. Lav. n. 13/I/****), su tutto il territorio nazionale.Che tu voglia inserirti nel mondo del lavoro, o sia alla ricerca di nuovi stimoli professionali, AB Lavoro è pronta a...
Trial Master File Associate
18 ore fa
3 giorni faJoin Our Team as a Trial Master File Associate - home based in Poland, Italy or Israel or hybrid in Barcelona, SpainAbout this roleAs part of our CDS Ophthalmology Trial Master File team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.The Trial Master File Associateis 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 Responsibilities :Notify 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 / 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 ManagerQualifications :At 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 Research 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.Master • Metropolitan City of Naples, Campania, .IT#J-*****-Ljbffr
