IT System Manager - Clinical Trial Supplies and Clinical Operations

Do you get excited about making good applications even better? And do you have an interest in understanding application configuration as well as business processes?

Then you might be our new IT System Manager.

Ascendis Pharma is a visionary and ambitious company, which offers you an opportunity to become involved in the development of ground-breaking therapies in a clinical setting.

You will be joining the new Product Team in Global IT that will be supporting our Clinical Trial Supplies and Clinical Operations business functions.

In Ascendis Pharma we are a cloud-first, zero legacy system environment. You will have excellent development opportunities in a very flexible environment where “the way we do things here” is open for discussion.

We are currently on a journey to implement agile methodology and a product-mindset in the ways we work, and we need you and the rest of Global IT to help us find our way moving forward.

As IT System Manager, you will be the expert in the applications your team supports. You will:

• understand how business requirements translate to configuration changes
• ensure the deployment, validation, and documentation of the changes
• ensure that the end-users get the training and support they need to get most out of the applications
• maintain a close relationship with the application vendors and understand which new features may benefit the business

Your main responsibilities are:

• Responsible for maintaining and improving our applications, including regulatory compliance (GxP)
• Ensure understanding of business processes and requirements, and translating these to technical requirements for the vendors to implement
• Work with the other members on the team to develop application roadmaps aligned with business and IT goals
• Coordinate with cross-functional stakeholders such as IT infrastructure, QA IT, Software vendors, support partners to ensure efficient delivery of applications changes
• Responsible for system administration and technical support, for instance ensure user administration and incidents are managed efficiently
• Develop training material and ensure well-trained user base
• Ensure periodic reviews are conducted to maintain compliance to GxP regulation
• Develop application documentation as per SDLC methodology and operational documentation such as SOPs, work instructions and user manuals
• Manage and maintain oversight over maintenance and support partners

The successful candidate has 5+ years of experience as a system manager, application analyst, solution architect, validation manager or something completely different. Ideally you have worked in a biotech, pharmaceutical company or consultancy catering to the pharmaceutical industry.

We know that talent can come in many shapes and forms. We expect you to have a Master’s degree, but which scientific field you’ll come from is secondary. The most important is that you are well versed in with IT processes, and that you have focus on how to create value with the business to help patients.

Ideally you also have:

• Experience with maintaining Clinical applications such as CTMS, eTMF, IRT, etc.
• Deep Clinical business process knowledge
• Experience with GxP validation such as 21 CFR Part 11 and GAMP5
• Experience defending application validation documentation in front of inspectors from Regulatory Authorities
• knowledge about, and surely an interest in agile methodology

As a person you are self-driven and ready to take responsibility from day one. You are agile at heart and more concerned about the results of your team than your individual success. Your approach is entrepreneurial and you enjoy finding solutions that meet the business needs. You think on your feet and keep your composure when things move quickly.

You are proficient in English at a professional level, both written and spoken.

Last but not least, you have a good sense of humor and enjoy working across cultures – with the work across time-zones it also entails.

We offer an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues on advancing an exciting product pipeline.

Travelling: Approx. 10-20 days/year

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea. We also have facilities in Heidelberg, Germany, as well as Princeton and Palo Alto, U.S.A. . Your international mindset and virtual presence is important to our global community.

If you want to know more about the position, please contact Ivanna Rosendal at [email protected] or Lene Larsen on M +45 22995471/ [email protected]. All applications must be in English and are treated confidentially.

Hellerup