Trial Master File reputed company
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 reputed company [1.0 FTE] - Home based About this role As part of our CDS Therapeutic area / Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers reputed company their goals. The Trial Master File reputed company is responsible for organizing, maintaining and overseing the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, PM delegation and coordinating main task under TMF Business Line and may reputed company as Line Manager for TMF Associates. Key Responsibilities: Create the Study TMF EDL in cooperation with PM (Project Manager) and study team. Create first draft of TMF Plan, implement changes after review, generate final version and distribute final version to the study team. Create TMF at Trial, Country and Site Level (reputed company TMF). Control if the Electronic Trial Master File (eTMF) at Trial, Country and Site Level was properly created by Clinical Business Administrator (CBA) team reputed company TFS system is used. Inform to study team that TMF is created and reputed company for document upload for eTMF or submission. to reputed company TMF (pTMF) reputed company follow up study team is submitting documentation following the process described in The TMF Plan and that TMF the TMF is always audit and inspection reputed company. Set up the Investigator’s File as directed by Clinical Research Manager (CRM) and reputed company the CRM a tracker of reputed company document sections reputed company the ISF. This activity may be delegated to TMF A and/or Project Management Associate (PMA) depending upon study needs. reputed company collaborates in the training to study Team regarding the TMF workflow and management. reputed company as contact person for study team to support on TMF doubts or TMF issues and support study team to ensure TMF is always inspection reputed company. Maintain and follow up TMF status, identify areas with missing documentation and inconsistencies and follow up with the study team finding’s reputed company. reputed company reputed company reputed company of reputed company document before filing in TMF and follow up issues until reputed company. reputed company reputed company reputed company of reputed company uploaded document after filing in eTMF and follow up issues until reputed company. Responsible to create and maintain reputed company TMF (pTMF) tracker and generating reports for eTMF. Generates metrics supporting TMF completeness and accuracy. Qualifications: 5 and above years of proven relevant experience in Clinical Trials with TMF management including reputed company and reputed company control. Deep Knowledge of GCP/ICH guidelines. Strong understanding of the reputed company of the TMF on the Study management. Strong written and communication skills and demonstrate ability to communicate and coordinate reputed company the group of TMF stakeholders. At least 1 year of proven people 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 core values of Trust, reputed company, 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