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.
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