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

Ascendis Pharma; Hellerup; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ascendis Pharma in Denmark is seeking a Technical System Manager to align clinical operations and trial supply systems (eTMF, CTMS, IRT) with our SaaS-based landscape. You will translate business needs into technical configurations, ensure validation and inspection readiness, and support audits.

You will report to the Global Head of Digitalization and work from Hellerup, Denmark. Travel up to 10–15 days per year is expected for cross-site collaboration and audits.

Qualifications

• Master's degree in engineering or a related technical field.
• 5+ years of experience with clinical systems in pharma.
• Experience with SaaS vendor management and GxP processes.

Responsibilities

• Be the technical expert for eTMF, CTMS and IRT solutions.
• Translate business needs into configuration specs for SaaS applications.
• Implement configurations yourself or coordinate with providers/vendors.
• Ensure systems are validated 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 and implement improvements for automation, integration and data flows.

Skills

Strong teamwork

Analytical mindset

Entrepreneurial mindset

Education

Master’s degree in Engineering or technical field

Tools

eTMF

CTMS

IRT

Job description

Are youatechnicalsystem managerwithdeepunderstanding ofclinical operations and clinical trial supplyprocess and data flows? Do you thinkholistically, act with ambition, andensurethe right functionality and system stability?

Can youensuregreat technical solutions,inspection-readinessand a great end-user experience forclinicalusers?

If so, you may be our newTechnicalSystem Manager.

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 passionateTechnicalSystem Manager. Youwillbe responsible forfinding the righttechnical solutionsfor ourclinical operations and clinical trial supplyteams focusing onIRT,CTMSand eTMF solutions.

Practically speaking, you will be the technical expert in howsystemsare configuredandmaintained. 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,AIand Analytics teams.

You will report to Ivanna Rosendal, Global Head of Digitalization, andJakobMonajemzadehThranePeople Leader. You will be based inHellerup,Denmark.

Your key responsibilities will be

• Be the technical expert ofeTMF, CTMS and IRT solutions
• Translatebusiness needsto specificationsof configuration needed in our SaaSapplications
• Eitherimplement the configurationsyourself, or work with the managed services provider or vendor to implement the configuration
• Ensure systemsarein a validated state andareinspection-ready
• Prepare and present our systems and the related documentation during audits and inspections
• Overseesystem supportand act as escalation point for tickets
• Maintainoperational oversightover vendors
• Facilitateend-user trainingand user groups
• Be visionary in improving ourtechnical capabilities andsuggest and implement improvementsfor automation,integrationandseamless data flows
• Assistwith documentation and validation of solutions
• Collaborate within and across the IT product teams when solving problems and delivering solutions

Qualificationsand experience

You hold a relevant academic degree – preferably aMaster’sdegree,witha background as an Engineer, System Manager or an equivalent technical role.

You haveSolidexperience with clinical systemsfrom apharma context,minimum+5 years of relevant experience across complex organizations.

Furthermore, you have:

• Strong understanding ofClinical Operations and Clinical Trial Supplyand their systems
• Experience withworking with SaaS vendors
• Experience withGxPprocessesfor system management

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