Job Description

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Brief Position Description:
The Application Specialist Senior - Veeva 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 Application Specialist (Senior) shall lead in resolving L2/L3 tickets and mentor/help Application Analysts for L1 ticket resolution for ensuring all defined KPI's and SLA's are met. The Application Specialist (Senior) provides training and technical support to clinical users, Application Analysts 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 & Vault Safety) & 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 & Vault Safety) & 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.
• 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.

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 Us:
Novotech is a global full-service clinical Contract Research Organization (CRO).
Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
About the Team:
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.

• Strategic vs transactional mindset.

• Ability to gain insights and make proactive decisions quickly.

• Culture that fosters partnership and collaboration, where every voice is heard and valued.

• Ongoing support from senior stakeholders and leadership team.

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