Technical System Manager - Clinical Operations and Clinical Trial Supply in IT

ASCENDIS PHARMA A/S

Gentofte Kommune

On-site

DKK 900,000 - 1,100,000

Full time

14 days+
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Job summary

Ascendis Pharma is seeking a Technical System Manager to drive technical solutions for clinical operations and trial supply. You will own configurations for eTMF, CTMS and IRT SaaS platforms, ensuring validated, inspection-ready systems and seamless data flows.

You will collaborate with Automation, Integration, AI and Analytics teams to extend functionality. You will report to the Global Head of Digitalization and be based in Hellerup, Denmark, working within an empowered Global IT team focused

Qualifications

  • Master’s degree preferred; engineering or similar technical background.
  • 5+ years of pharma or clinical operations systems experience.
  • Experience with SaaS vendors and validation.

Responsibilities

  • Be the technical expert of eTMF, CTMS and IRT solutions.
  • Translate business needs to configurations in SaaS applications.
  • Implement configurations or coordinate with MSPs/vendors.
  • Ensure systems are in a validated state and inspection-ready.
  • Prepare and present systems documentation during audits/inspections.
  • Oversee system support and act as escalation point for tickets.
  • Maintain operational oversight over vendors.
  • Facilitate end-user training and user groups.
  • Suggest improvements for automation, integration and data flows.

Skills

Clinical systems
SaaS vendors
GxP processes

Education

Master’s degree in Engineering or related

Job description

Are you a technical system manager with deep understanding of clinical operations and clinical trial supply process and data flows? Do you think holistically, act with ambition, and ensure the right functionality and system stability?

Can you ensure great technical solutions, inspection-readiness and a great end-user experience for clinical users?

If so, you may be our new Technical System Manager.

Ascendis Pharma

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

Our Context

This position is based in our Global IT organization. In Global IT, we have spent the past five years building and maturing a product-driven organization. We operate with a strong focus on product management and lifecycle thinking, where long-lived teams take full ownership- from problem discovery to solution delivery and continuous improvement - ensuring we address real business needs.

Our structure combines clear leadership intent with empowered teams: each team member is supported by both a People Leader focused on development and a Functional Leader guiding strategy and delivery. We foster autonomy and self-organization to enable fast flow, clear accountability, and minimal dependencies.

The Clinical domain currently consists of three product teams and a data team, supporting our Clinical Operations, Clinical Development, Biometrics, Clinical Data Management and Clinical Trial Supply functions.

We are Seeking

We are seeking a passionate Technical System Manager. You will be responsible for finding the right technical solutions for our clinical operations and clinical trial supply teams focusing on IRT, CTMS and eTMF solutions. Practically speaking, you will be the technical expert in how systems are configured and maintained. All of these are SaaS solutions. When our SaaS solutions fall short, you will find ways to deliver functionality in collaboration with our Automation, Integration, AI and Analytics teams.

You will report to Ivanna Rosendal, Global Head of Digitalization, and Jakob Monajemzadeh Thrane People Leader. You will be based in Hellerup, Denmark.

Your Key Responsibilities Will Be To
  • Be the technical expert of eTMF, CTMS and IRT solutions
  • Translate business needs to specifications of configuration needed in our SaaS applications
  • Either implement the configurations yourself, or work with the managed services provider or vendor to implement the configuration
  • Ensure systems are in a validated state and are inspection-ready
  • Prepare and present our systems and the related documentation during audits and inspections
  • Oversee system support and act as escalation point for tickets
  • Maintain operational oversight over vendors
  • Facilitate end-user training and user groups
  • Be visionary in improving our technical capabilities and suggest and implement improvements for automation, integration and seamless data flows
  • Assist with documentation and validation of solutions
  • Collaborate within and across the IT product teams when solving problems and delivering solutions
Qualifications and Experience

You hold a relevant academic degree – preferably a Master’s degree, with a background as an Engineer, System Manager or an equivalent technical role.

You have solid experience with clinical systems from a pharma context, minimum +5 years of relevant experience across complex organizations.

Furthermore, you have:

  • Strong understanding of Clinical Operations and Clinical Trial Supply and their systems
  • Experience with working with SaaS vendors
  • Experience with GxP processes for system management
Key Competencies

You are a strong team player, analytical, and have a can-do attitude. You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key. To succeed in this role, we also expect you to be good at collaborating with business in complex and ambiguous settings, handling conflicts constructively, and helping groups move forward.

What We Offer

We offer an exciting and challenging position in an entrepreneurial and international company with short decision paths. You will work with highly skilled colleagues and play a key role in shaping how Global IT delivers sustainable value to Ascendis Pharma and, ultimately, to patients.

Travel

10-15 days per year

Office

Tuborg Boulevard 12, 2900 Hellerup

Flexibility

Some of the Clinical organization is located in the US, and meetings in the afternoon and evening will occur.

Location

Hellerup

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