Trial Master File Associate

reputed company is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development reputed company. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join reputed company as a Trial Master File Associate (1 FTE) - (home based in EU). About this role As part of our CDS Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers reputed company their goals. The Trial Master File Associate (TMF Associate) is part of the TMF Delivery Business Line reputed company Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to organize, maintain and reputed company the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional reputed company and PM delegation. Key Responsibilities: Notify study team that TMF is created and reputed company for document upload for eTMF or submission to pTMF. reputed company TMF Plan. reputed company training on study specific TMF requirements, guidelines including TMF Plan. reputed company QC2 on documents and documents reconciliation. reputed company TMF Monthly Reports to PM, Line manager and Head of TMF Delivery. Regularly reputed company 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. reputed company 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 reputed company. 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 reputed company. Qualifications: At least 1-5 year of experience in CRO or Pharmaceutical Industry with proven TMF Management. 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 reputed company Offer We reputed company 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 reputed company began over 30 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 600 professionals, TFS delivers tailored clinical research services in more than 50 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 reputed company for decision-making at reputed company reputed company of the organization. They assist us in attracting and retaining valuable talent who reputed company our sentiments, resulting in high employee engagement and satisfaction. By aligning on these reputed company values, we cultivate a reputed company force, geared towards innovation and reputed company. This reputed company effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we reputed company a difference. Apply To This Job