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

Reposted 12 Days Ago
Be an Early Applicant
Hiring Remotely in Hellerup, DNK
Remote
Senior level
Biotech • Pharmaceutical
The Role
Serve as technical expert for eTMF, CTMS and IRT SaaS solutions supporting Clinical Operations and Clinical Trial Supply. Configure and validate systems, manage vendors and managed services, ensure inspection-readiness, oversee support and training, escalate tickets, and drive automation, integration and data flow improvements in collaboration with IT product teams.
Summary Generated by Built In

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 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 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 Clinicial organization is located in the US, and meetings in the afternoon and evening will occur 

Apply now.  

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.     

To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated. 

For more details about the position or the company, please contact Jakob Monajemzadeh Thrane, People Leader, [email protected].   

  

You can learn more about Ascendis by visiting our website,       

Applications must be submitted in English and will be treated confidentially.  


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


A note to recruiters:   

We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.  If this occurs, your ownership of these candidates will not be acknowledged. 

Skills Required

  • Relevant academic degree (engineering, system management or equivalent)
  • Master's degree
  • Minimum 5 years experience with clinical systems in a pharmaceutical context
  • Practical experience with eTMF, CTMS and IRT systems
  • Experience working with SaaS vendors and managed service providers
  • Knowledge and experience with GxP processes for system management
  • Experience with system validation, inspection readiness and related documentation
  • Vendor oversight and operational support escalation experience
  • Experience driving automation, integrations and data flows with cross-functional IT teams
  • Strong collaboration, analytical skills and ability to work in ambiguous settings
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Hellerup
834 Employees
Year Founded: 2007

What We Do

Ascendis Pharma is applying its innovative TransCon technologies to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, Palo Alto and Redwood City, California, and Princeton, New Jersey.

Similar Jobs

Milestone Systems Logo Milestone Systems

AI Harness Engineer

Artificial Intelligence • Security • Software • Analytics • Big Data Analytics
Remote or Hybrid
2 Locations
1500 Employees

Deepgram Logo Deepgram

Account Executive

Artificial Intelligence • Machine Learning • Natural Language Processing • Software • Conversational AI
In-Office or Remote
28 Locations
150 Employees

Zapier Logo Zapier

Engineer, Applied AI

Artificial Intelligence • Productivity • Software • Automation
Remote
29 Locations
800 Employees
192K-287K Annually

Coinbase Logo Coinbase

Controller

Artificial Intelligence • Blockchain • Fintech • Financial Services • Cryptocurrency • NFT • Web3
Easy Apply
Remote
26 Locations
4700 Employees
79K-88K Annually

Similar Companies Hiring

SOPHiA GENETICS Thumbnail
Software • Healthtech • Biotech • Big Data • Artificial Intelligence
Boston, MA
450 Employees
Pfizer Thumbnail
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
New York, NY
121990 Employees
Cencora Thumbnail
Healthtech • Logistics • Pharmaceutical
Conshohocken, PA
51000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account