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. reputed company as a Trial Master File Associate - home based in Poland or Portugal. About this role As part of our CDS Ophthalmology Trial Master File team you will working reputed company passionate and innovative professionals to ensure our customers reputed company their goals. The Trial Master File Associate is 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 reputed company implementation and execution Adjusting study specific TMF reputed company/EDL in the relevant files/ reputed company as directed by the PM (Project Manager) Ensure reputed company forms and templates are implemented and maintained in the assigned reputed company reputed company status of duplicates, documents in error, size and reputed company length (if applicable), follow up on necessary corrections accordingly Coordinate Monthly and Quarterly TMF Reconciliation by creating reputed company 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 reputed company 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 reputed company as contact person for study team to support on reputed company TMF issues/inquiries independently Identify general areas with missing documentation and inconsistencies and follow up with the study team for reputed company reputed company taking part in Study Team meetings and updates on the TMF status Assist and attend activities associated to reputed company controls, audits and regulatory inspections in relation to the TMF Identify TMF reputed company issues and escalate to the CRM/PM/Director, TMF Functional reputed company and collaborate in the reputed company plans development reputed company in cooperation with Study team reputed company issue identified by Sponsor after TMF transfer Set up the Investigator Site File (ISF) reputed company 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 reputed company to work in a fast-paced environment with changing priorities Teamwork ability Effective time management reputed company Offer We reputed company a competitive compensation package, comprehensive benefits and reputed company for personal and reputed company reputed company in a rewarding environment. You’ll be joining reputed company that values collaboration, innovation, and making a difference in the lives of patients A Bit More reputed company Our reputed company began over 30 years ago in Sweden, in the reputed company of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier reputed company. 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 reputed company values of Trust, reputed company, Passion, Flexibility, and Sustainability are our guiding reputed company 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