Lavori attuali relativi a Trial Master File Associate - Roma - TFS HealthScience
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Trial Master File Associate
2 giorni fa
Giuliano di Roma, Italia Iriscube Reply A tempo pieno3 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...
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Trial Master File Associate
1 settimana fa
Giuliano di Roma, Italia Ashby A tempo pieno3 giorni faTFS 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...
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Trial Master File Associate
2 settimane fa
Roma, Italia European Institute of Policy Research and Human Rights SIA A tempo pienoRemotoEUR 50.000 - giorni fa 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...
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Trial Master File Specialist – Remote/Hybrid Europe
2 settimane fa
Roma, Italia TFS HealthScience A tempo pienoA leading global Contract Research Organization is seeking a Trial Master File Associate. This role involves overseeing trial master files, ensuring regulatory compliance, and supporting study teams in achieving their goals. Applicants should have a background in health sciences and at least 3 years of TMF experience. The position offers a competitive...
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Trial Master File Associate
2 settimane fa
Roma, Italia TFS HealthScience A tempo pienoTFS 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...
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TMF Master File Associate — Remote/Hybrid Europe
1 settimana fa
Giuliano di Roma, Italia Ashby A tempo pienoA leading Contract Research Organization is seeking a Trial Master File Associate to manage the Trial Master File (TMF). The role involves organizing and maintaining TMF compliance according to regulations and collaborating with study teams. Ideal candidates have TMF management experience and a Bachelor's degree in Health Science. This position offers...
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Remote TMF Associate
2 settimane fa
Roma, Italia European Institute of Policy Research and Human Rights SIA A tempo pienoA leading global Contract Research Organization seeks a Trial Master File Associate to manage the Trial Master File and ensure compliance with regulations. Candidates should have 3+ years of TMF experience and a Bachelor’s Degree in Health Science. This home-based role can be in Italy or hybrid in Spain. Join a collaborative and innovative team focused on...
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Global Clinical Trial Ops
2 giorni fa
roma, Italia Planet Pharma A tempo pienoA leading pharmaceutical company is seeking a Clinical Trial Associate (CTA) in Turbigo, Italy, to provide operational support to the global clinical team. The role is vital in maintaining quality systems and documentation compliance. Ideal candidates will have a Bachelor's degree in a related field and be fluent in both English and Italian. Experience in...
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Remote Director, Project Delivery: TMF
3 settimane fa
Roma, Italia TFS HealthScience A tempo pienoA global Contract Research Organization is seeking a Director of Project Delivery to lead their Trial Master File and Clinical Research Associate teams. The role involves providing strategic oversight and operational management for clinical trials. The ideal candidate must have a Bachelor's in life science, at least 9 years of relevant industry experience,...
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Lead Clinical Research Associate
4 giorni fa
Roma, Italia TFS HealthScience A tempo pienoJoin to apply for the Lead Clinical Research Associate role at TFS HealthScience . LEAD CRA FREELANCE 0.5 FTE - REMOTE (ITALY) 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...
Trial Master File Associate
9 ore fa
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. About this role As part of our CDSOphthalmology Trial Master File team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.The Trial Master File Associate is 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 pTMF Develop TMF Plan Provide training on study specific TMF requirements, guidelines including TMF Plan Perform QC2 on documents and documents reconciliation Provide TMF Monthly Reports to PM, Line manager and Head of TMF Delivery Regularly check TMF metrics, follow up on detected issues, ensure acceptable level of metrics Ensure TMF processes timely implementation and execution Adjusting 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 projects Check status of duplicates, documents in error, size and path length (if applicable), follow up on necessary corrections accordingly Coordinate Monthly and Quarterly TMF Reconciliation by creating Action Plan and submitting relevant report on the status Ensure TMF AoR completion and monitoring TMF transfer/shipment to the Sponsor Ensure delivery of fully executed TMF AoR to TMF Functional lead Actively 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 ready Act as contact person for study team to support on all TMF issues/inquiries independently Identify general areas with missing documentation and inconsistencies and follow up with the study team for resolution Actively taking part in Study Team meetings and updates on the TMF status Assist and attend activities associated to quality controls, audits and regulatory inspections in relation to the TMF Identify TMF quality issues and escalate to the CRM/PM/Director, TMF Functional lead and collaborate in the action plans development Resolve in cooperation with Study team all issue identified by Sponsor after TMF transfer Set up the Investigator Site File (ISF) Actively contribute to the organization and development of routines to enhance the work at TFS Develops and maintains an effective relationship with the study teams Other, as identified by Line Manager Qualifications 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 preferred Knowledge of GCP/ICH guidelines Good written and communication skills Good organizational and multi-tasking skills Good software and computer skills Able to work in a fast-paced environment with changing priorities Teamwork ability Effective time management What We Offer We 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 patients A Bit More About Us Our 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. #J-18808-Ljbffr
