Technical Solution Designer - Clinical Trial Mgmt & Clinical Trial Supply in IT

Ascendis Pharma

Gentofte Kommune

Sur place

DKK 900 000 - 1 100 000

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Résumé du poste

Ascendis Pharma is seeking a Technical Solution Designer in Denmark to configure CTMS, eTMF and IRT SaaS systems for Clinical Trial Management and CTS. You will partner with IT product teams and external vendors to deliver compliant, scalable solutions.

Reporting to the Clinical Domain Lead and People Leader, the role is based in Hellerup. Travel 10–15 days per year, collaborating with global teams in an innovative, fast-moving environment.

Qualifications

  • Master's degree preferred; background as Engineer/Technical Business Analyst/Configuration Manager or equivalent.
  • 3+ years of experience with eTMF and CTMS in a GxP context.
  • Strong understanding of Clinical Trial Management & Clinical Trial Supply systems.
  • Experience with SaaS vendors and configuring SaaS solutions.
  • Ability to connect people and create shared direction in complex settings.

Responsabilités

  • Design and implement technical configuration for CTM and CTS.
  • Engage with stakeholders to understand business needs.
  • Implement configurations yourself or coordinate with MSP/vendor.
  • Oversee system support and act as escalation point for tickets.
  • Assist with documentation and validation of solutions.
  • Improve CTM/CTS capabilities via automation, integration and data flows.
  • Ensure systems are validated and inspection-ready.
  • Maintain operational oversight over vendors.

Connaissances

CTMS
eTMF
GxP compliance
SaaS configurations
Vendor management
Cross-functional collaboration
Technical problem solving

Formation

Master's degree

Outils

CTMS
eTMF

Description du poste

Are you a Technical Solution Designer with deep understanding of Clinical Trial Management and Clinical Trial Supply? Do you think holistically, act with ambition, and find technical solutions to accelerate clinical trial oversight?

Can you design and implement configurations for SaaS applications to support trials?

If so, you may be our new Technical Solution Designer.

Ascendis Pharmais 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 thatdemonstratebest-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, andadditionaloffices 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 basedinour Global IT organization. In Global IT, we have spent the past five years building and maturing a product-driven organization. Weoperatewith 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 addressreal businessneeds.

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.

TheClinical domaincurrently 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

a passionateTechnicalSolution Designer who will be responsible for designing and implementing technical solutions to support CTM and CTS. Practically speaking, you will be the technical expert in how our CTMS, eTMF, and IRT are configured. 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.

Together with the IT product team, you will ensure that the solutions, including the documentation packages we deliver, are GxP compliant and sustainable.

You will report to Simon Rønne Kümmel, Clinical Domain Lead, and Jakob Thrane, People Leader. You will be based in Hellerup, Denmark.

Your key responsibilities will beto
  • Design and implement technical configuration and solutions to support CTM and CTS
  • Engage with stakeholders to understand business needs
  • Either implement the configurations yourself, or work with the managed services provider or vendor to implement the configuration
  • Oversee system support and act as escalation point for tickets
  • Assist with documentation and validation of solutions
  • Be visionary in improving our CTM and CTS supply technical capabilities and suggest and implement improvements for automation, integration and seamless data flows
  • Ensure systems are in a validated state and are inspection-ready
  • Maintain operational oversight over vendors
Qualificationsand experience

You hold a relevant academic degree - preferably aMaster'sdegree,witha background as an Engineer, Technical Business Analyst, Configuration Manager or an equivalent technical role.

You have solid experience with eTMF and CTMS in a GxP context, minimum +3 years of relevant experience across complex organizations.

Furthermore,you have:

  • Strong understanding of Clinical Trial Management and Clinical Trial Supply and related systems
  • Experience working with SaaS vendors
  • Ability to connect people and create shared understanding and direction
  • Is good at collaborating with business in complex and ambiguous settings, handling conflicts constructively and helps groups move forward

You area strong teamplayer, analytical, and have a can-do attitude.

Youpossessan 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 begood at collaborating withbusinessin complex and ambiguous settings, handling conflicts constructively, and helping groups move forward.

Travel

10-15daysperyear

Flexibility

Some of theClinicialorganizationis located inthe US, and meetings in the afternoon and evening will occur.

For more detailsabout the position or the company, please contactJakob Monajemzadeh Thrane, People Leader,jmt@ascendispharma.com.

You can learn more about Ascendis by visitingour website,

Applicationsmust besubmittedin English and will be treated confidentially.

As the summer holiday period approaches, you may experience a longer response time than usual. Wetruly appreciateyour patience and thank you for your understanding. We look forward to reviewing your application as soon as possible.

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