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The IT System Manager role for the Clinical IT team at Ascendis pharma, your role is to ensure stable operations for our existing applications. You will be a part of the IT product team that develops, implements, manages, maintains, and supports Clinical business applications and systems for the Biometrics and Pharmacometrics modelling business functions.

The individual in this position is responsible for the applications and solutions that are already in production. This will require understanding the business process, user and functional requirements, and configurations surrounding the use of the system. You will work with a cross functional team to help configure, deploy and maintain the system capabilities and/or upgrades in a GxP compliant way.

You will join the Ascendis Pharma Global IT, Continuous Delivery organization, consisting of product teams delivering to business value streams. Ascendis is on a journey to a more agile based approach. We are a cloud-based, mainly outsourced environment.

• Serve as the System Manager for IT Systems enabling Clinical business processes with technology platforms such as Veeva EDC, Statistical Computing Environments and Pharmacometrics Modelling environment.
• Support Integrations across Clinical Applications such as eTMF, EDC, CTMS and IRT.
• Be able to provide technical leadership for the systems currently live in this space and be able to do some solution architecture.
• Responsible for the software solution including processes, requirements and configurations surrounding the use of system; including regulatory (GxP, SOX) compliance, where applicable.
• To coordinate and manage continuous improvement of IT Systems and processes across Ascendis.
• Act as a trusted advisor for internal stakeholders and a liaison to suppliers of relevant services supporting the above areas; manage stakeholder expectations and ensure business needs are understood and supported with current and planned functionality.
• Perform design/code/build reviews to ensure software code and configurations meet standards.
• Develop and manage business relationships with software partners, vendors, and service providers to ensure value realization on our investments.
• Coordinate with cross-functional stakeholders such as IT Infrastructure, QA, Business Owners, Software vendor etc., to ensure project deliverables meet business expectations and timelines.
• Responsible for system administration and technical support, including ticket resolution, release management and end user training.
• Provide guidance to the support team members on the resolution and process.
• Escalation and coordination of support requests to software vendors and integration partners.
• Conduct periodic reviews, user Reviews and other compliance activities to make system compliant to follow the GxP regulations.
• Estimated compensation: 160-170K/year

Requirements

• Bachelors degree in a related discipline and a minimum of 5 years of progressively responsible experience in related roles in a pharmaceutical, biotechnology or related environment.
• Understanding of Clinical space in life sciences and experience with these application/technologiess: SaaS, PaaS, Azure, Veeva , Integrationsand Platform management
• Experience in implementing technology roadmap under a defined corporate methodology.
• Sufficient technical understanding to challenge our technology partners
• Experience in helping across all aspects of Software Development Life Cycle (SDLC) and Validation Lifecycle (VLC) methodology.
• Experience defending computer system validation packages making them inspection ready and defend in front of auditors (external/internal).
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance