IT System Manager (00031)
Ascendis Pharma
ABOUT ASCENDIS PHARMA, INC.
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and established advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany, Princeton, New Jersey, Redwood City, and Palo Alto, California.
Duties: Serve as the System Manager for IT Systems enabling commercial and Medical Affairs business processes with technology platforms such as Veeva CRM, Commercial Data warehouse, Salesforce Marketing Cloud, Veeva PromoMats, Veeva MedComms, Case Management, Grant Management etc. Responsible for the software solution including processes, requirements and configurations surrounding the use of system, including regulatory (GxP, SOX) compliance, where applicable. 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. Facilitate workshops and translates user needs into user requirements and use cases. Work closely with solutions architect to identify the optimum combination of applications that meet the requirements of business functions. Develop short-term and long-term roadmaps aligned with business goals and technology governance. Lead a team responsible for the implementation and maintenance of system capabilities and/or upgrades. Perform design/code/build reviews to ensure software code and configurations meet standards. 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. Work directly with customers to probe and ask effective questions in order to fully diagnose both the root cause of a problem and the customer’s comfort level with technology. Contribute to the support and maintenance of validation package in compliance with validation/documentation procedures as per SDLC methodology. Contribute to the support and maintenance of operational documentation including SOPs, work instructions, manuals, and training materials for end users and system administrators. Assist with critical data support and data analysis requests from internal stakeholders. Monitor system infrastructure health and performance regularly to ensure continuous system availability for 24x7 operational sites. Remediate security vulnerabilities on time to mitigate any security risks associated with the system software or server infrastructure. Communicate pertinent system information to site/project leadership as needed. Tools used include: Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, and Compliant GxP Computerized Systems (GAMP5), SOX, Agile methodologies, Veeva CRM, Commercial Data warehouse, Salesforce Marketing Cloud, Veeva PromoMats, Veeva MedComms, Case Management, and Grant Management.