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

Ascendis Pharma; Hellerup; In loco; DKK 700.000 - 1.100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Travel opportunities

Office in Hellerup

Flexible schedule

Descrizione del lavoro

Ascendis Pharma is seeking a Technical Solution Designer in Denmark to architect and implement technical configurations for CTM and CTS, focusing on CTMS, eTMF, and IRT across SaaS platforms. You will be the technical expert guiding configuration decisions and collaborating with Automation, Integration, AI and Analytics teams.

You will report to the Clinical Domain Lead and People Leader, based in Hellerup, Denmark, with a focus on delivering compliant, scalable solutions across global trials.

Competenze

• Master’s degree preferred in engineering, IT, or a related field.
• Solid experience with eTMF and CTMS in a GxP context.
• Proven ability to configure and optimize SaaS CTMS/eTMF/IRT systems.

Mansioni

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

Conoscenze

CTMS expertise

eTMF experience

SaaS configurations

Stakeholder collaboration

Formazione

Master's degree preferred

Strumenti

SaaS platforms

Descrizione del lavoro

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.

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.

Key competencies:

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.

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, topatients.

Travel

10-15daysperyear

Office

Tuborg Boulevard 12, 2900 Hellerup

Flexibility

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