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Senior Clinical Systems Specialist
2 weeks ago
This senior-level position provides specialized support for clinical systems and IT applications with GxP categorization. The successful candidate will be responsible for ensuring optimal system performance, managing system enhancements, and leading in resolving complex technical issues.
- Responsibilities:
- Provide high-level support for clinical (CTMS, eTMF & Vault Safety) & IT systems with GxP categorization as per company defined SLA's.
- Manage user access and user roles for clinical (CTMS, eTMF & Vault Safety) & IT systems with GxP categorization as per applicable 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 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.
At Novotech, we offer a great workplace that is committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
We are passionate about working in clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
Our team members are empowered to make proactive decisions quickly, and we foster a culture that values partnership and collaboration.
About UsNovotech 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. We employ over 3000 employees and have over 5000 site partnerships.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas.
About the TeamAt Novotech, we have advanced therapeutic and regulatory expertise, and the ability to execute across markets. Our client-centric service model means that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market.
- 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.
