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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 Study Start Up Lead in Australia (home based) - 1 FTE for next 3 months, then 0.2 FTE for additional 3 months - About this role As part of our CDS - Dermatology, Inmunology, Internal Disease area- team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Study Start Up Lead is responsible for coordination and overview of startup activities from projects are awarded till last participant site is activated, ensuring the startup deliverables and timelines are achieved. The Study start up lead will work in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations. The Study start up lead will plan and pro-actively coordinate, together with the study PM, the study startup activities to ensure key milestones are achieved and start up is performed within budget, on schedule and in compliance with the appropriate - quality standards. Key Responsibilities:  Ensure all startup activities for projects are performed on-time, within the scope and budget and in compliance with ICH/GCP guidelines, SOPs and protocol requirements. Together with the study Project Manager, manages the strategic aspects of projects startup and mitigating any risk setting up the proper action plan. May oversight and coordinate SSU Specialists, assigned to their programs being the initial point of contact and supporting them with startup activities and investigative sites liaison. This case will ensure all assigned SSU Specialist are adequately trained on project specific systems and procedures. Develop and maintain Startup plan and timelines for their projects and track progress ensuring project deliverables and milestones are reached. May manage the resource allocation of Start Up team on the project, in collaboration with respective line managers. Responsible of coordinating EC/IRB submissions or any other notification requested as well as coordination with Regulatory department regarding HA/CA submissions/notification. Ensure and oversight the proper aadaptation of Subject Information and Informed Consent documents according to local law and requirements. Together with the Legal Department, coordinate the Clinical trial Agreements negotiation supporting the SSU Specialists and CRAs on handling the negotiation properly and on time. Coordinate site evaluation and feasibility process for assigned projects. Ensure all Start Up documentation is submitted properly and on time to the Trial master File. Assist the Project Manager ensuring the Project is properly set up in CTMS and all information related to start up activities is properly updated. Support the Project Manager coordinating the greenlight and site activations process and ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized, and specific project deliverables are completed. Measure and evaluate project startup deliverables and metrics. Update the Project Manager with status of start-up progress and ensure a proper escalation of any issue detected. Qualifications:  Bachelor’s Degree, preferably in life science or nursing; or equivalent. Minimum 4 years of experience in any relevant Clinical Operations experience related to Start Up procedures. Able to work in a fast-paced environment with changing priorities. Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas. Possess the understanding of Good Clinical Practice regulations, ICH guid