Technical System Manager Clinical Operations and Clinical Trial Supply in IT
Gentofte Kommune - Denmark
Job Summary
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 solutionsinspection-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 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 seekinga passionateTechnicalSystem responsible forfinding the righttechnical solutionsfor ourclinical operations and clinical trial supplyteams focusing onIRTCTMSand eTMF solutions.
Practically speaking you will be the technical expert in howsystemsare of these are SaaS our SaaS solutions fall short you will find ways to deliver functionality in collaboration with our Automation IntegrationAIand Analytics teams.
You will report to Ivanna Rosendal Global Head of Digitalization andJakobMonajemzadehThranePeople Leader. You will be based inHellerupDenmark.
Your key responsibilities will beto
- 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 automationintegrationandseamless 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 aMastersdegreewitha background as an Engineer System Manager or an equivalent technical role.
You haveSolidexperience with clinical systemsfrom apharma contextminimum5 years of relevant experience across complex organizations.
Furthermoreyou 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
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 pleasesubmitit through the specified platform - applications sent by email or other channels will not be evaluated.
For more detailsabout the position or the company please contactJakob Monajemzadeh Thrane People
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.
A note to recruiters:
We do not allow external search party of candidates without written permission from theAscendisPharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not this occurs your ownership of these candidates will not be acknowledged.
Required Experience:
Manager
About Company
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a ... View more