Job Description

JOB DESCRIPTION Brief Position Description: The Senior Clinical Systems Administrator (SCSA) supports the day to day operations of Clinical Systems/ IT applications (with GxP categorization), ensuring optimal system performance and managing system enhancements. In addition, the SCSA shall lead in resolving L2/L3 tickets and mentor/help CSA\'s for L1 ticket resolution for ensuring all defined KPI\'s and SLA\'s are met. The SCSA provides training and technical support to clinical users, CSA\'s and contributes to the review and maintenance of processes, tools and standards Minimum Qualifications & Experience: Degree in a related field computer science, information technology and/or information systems. Experience in clinical trial systems supporting the CRO and/or Pharmaceutical industry is advantageous. Responsibilities: . Provide L2/L3 support for clinical (CTMS, eTMF & Argus) & IT systems with GxP categorization (e.g. LMS, BI application etc) as per company defined SLA\'s in different shifts to the users (internal and external) spread across different geographical regions (ANZ/Asia/Europe/USA). . Manage user access and user roles for clinical (CTMS, eTMF & Argus) & IT systems with GxP categorization (e.g. LMS, BI application etc) as per applicable Novotech IT SOP\'s. . Responsible for clinical IT systems/applications training to all regions & Users and act as knowledge expert for the systems. . Primary liaison with vendors and Novotech IT for maintenance changes and upgrades. . Lead and deliver UAT testing for system upgrades, new release(s) and change management in collaboration with Clinical Systems, IT and business users. . Serve as system administrator and post-production end-user support including helpdesk management. . Reporting of clinical IT systems/applications status to system owners and/or senior management. . Be responsible for User instructions development, implementation, set-up and maintenance. . Set up of new projects/study, system specific templates/checklist, LOV\'s, workflows etc . Provide various reports from Clinical / IT Systems (with Gxp Categorization) in the form of data extracts from database (via SQL queries) as per study/ user requirements. . In collaboration with the Clinical Operations and other applicable departments, assist in the development of new training materials, procedures and revision of current SOPs and guidelines as requested. . Remain abreast of new developments in the systems and suggest improvements to drive efficiencies that benefit Novotech and end User as well as client services. . Understand company processes in areas relevant to a CSA and be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out the SCSA role. . Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. ABOUT THE TEAM Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

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