Senior Clinical Systems Administrator

Novotech

India
Permanent
Full-time

25 days ago

Job Description:Brief Position Description:The Clinical Systems Administrator (CSA) supports the day-to-day operations of Clinical Systems/ IT applications (with GxP categorization), ensuring optimal system performance and managing system enhancements. The CSA provides training and technical support to clinical users 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 required

Responsibilities:

Provide L1/L2 support for clinical (Veeva Vault, CTMS, eTMF & Safety) & IT applications with GxP categorization (e.g., LMS, BI application etc) as per company defined SLA's
Shall be able to work in different shifts to provide application support for the users (internal and external) spread across different geographical regions (ANZ/Asia/Europe/USA).
Manage user access and user roles for clinical systems (Veeva Vault, CTMS, eTMF & Safety) & IT applications 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.
Perform UAT testing for system upgrades, new release(s) and change management in collaboration with Clinical Systems, IT, and business users.

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 has offices in 11 geographies across the region, and site partnerships with key medical institutions.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: 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.

Novotech

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