Clinical Systems Specialist - Job ID: 2061
Ascendis Pharma
Summary
Are you passionate about helping people working on clinical trials with their system-related problems and ensure that the right steps are taken to avoid those problems repeating themselves? Do you have experience with supporting IT applications and with understanding and structuring user needs? If so, now is your chance to join Ascendis Pharma as our new Clinical systems specialist for the clinical domain.
Job description
This position is based in our Global IT organization. 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. Our portfolio of systems (eTMF, CTMS, IRT, eCOA, SCE, CDR, and related tools) are, almost exclusively, Software as a Service (SaaS) solutions, which are made available to use at Ascendis Pharma through external vendor collaboration.
We are seeking a self-driven clinical systems specialist to join our growing team. As a key member of the Global IT team and the clinical domain, you will play a crucial role in supporting the clinical trial staff with their use of the clinical systems. This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional, global teams working together to achieve extraordinary results. You will report to Saman Sadhar, People Leader in Global IT, and to Simon Rønne, Domain lead, from a functional point of view. You will be based in Princeton, NJ.
Your key responsibilities will be:
- Acting as the first point of contact for any system or user-driven issue that is reported by end-users of our clinical IT systems.
- Collaborate with the product teams in the clinical domain to provide short-term solutions for errors and identify long-term steps to solve the root cause of recurring issues.
- Provide guidance and help interpret training materials to ensure end-users feel comfortable in using our systems in an efficient way, guided by Global IT and business processes.
- Proactively reach out to key users to identify patterns of use that might lead to future issues or will require system change to ensure optimal use.
- Create structure and overview of issues and issue-patterns that will enable insights around the use of our system for the clinical product teams, as well as domain and business leadership.
Qualifications and Skills:
You hold a relevant academic degree – minimum a bachelor’s degree – and 3+ years of experience from a related role in a pharmaceutical, biotechnology or related environment, preferably in an IT support or configurator role.
Furthermore, you have:
- Experience working within GxP regulated IT systems and tools in an admin context.
- Hands-on experience with supporting users in SaaS systems.
- Experience with identifying and documenting user requirements and delivering to those requirements in a team setting.
- Been working in an agile setting and thrive in a “continuous improvement” environment.
- Experience with hands-on configurations and related documentation in IT systems is a plus.
Key competencies:
You are a strong team player, innovative and curious, and have a can-do attitude. You are comfortable working across cultures and can readily adapt to changing priorities. You are comfortable interacting with all types of users, both through in-person interactions and by way of our ticketing system. You have a technical and user-centric mindset, where you pragmatically balance workarounds and long-term solutions to problems. To succeed in this role, we also expect you to be self-driven and able to seek opportunities for improvement and take initiative to move things forward.
Travel: 5 – 10 days per year. Office: Princeton, NJ, United States
Requirements
- Minimum bachelor's degree
- 3+ years of experience in a related role in pharmaceutical, biotechnology or related environment
- Experience working within GxP regulated IT systems and tools in an admin context
- Hands-on experience with supporting users in SaaS systems
- Experience with identifying and documenting user requirements and delivering to those requirements in a team setting
- Experience working in an agile setting
- Experience with hands-on configurations and related documentation in IT systems is a plus
- Strong team player, innovative and curious, can-do attitude
- Comfortable working across cultures and adapting to changing priorities
- Comfortable interacting with all types of users, both in-person and via ticketing system
- Technical and user-centric mindset
- Self-driven and able to seek opportunities for improvement
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-Term Disability
- Pet Insurance
- Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Savings Account
- Flexible Spending Accounts
- Incentive Compensation Plans
- Accident, Critical Illness, Hospital Indemnity
- Mental Health Resources
- Paid Parental Leave
Company overview
Ascendis Pharma is a global biopharmaceutical company founded in 2007 and headquartered in Hellerup, Denmark, with additional facilities across Europe and the United States. The company is publicly traded on Nasdaq under the symbol ASND. Ascendis Pharma specializes in applying its innovative TransCon technology platform to develop novel therapies that address unmet medical needs in endocrinology rare diseases and oncology. The company's core values of Patients, Science, and Passion guide its mission to create potentially best-in-class therapies. Ascendis has two marketed products: SKYTROFA (lonapegsomatropin-tcgd) for pediatric growth hormone deficiency and YORVIPATH (palopegteriparatide) for adult hypoparathyroidism. The company's pipeline includes TransCon CNP for achondroplasia and oncology candidates like TransCon TLR7/8 Agonist and TransCon IL-2 β/γ. With approximately 1,017 employees globally as of December 2024, Ascendis operates through a combination of direct commercialization in key markets and strategic partnerships in regions like Greater China and Japan through VISEN Pharmaceuticals and Teijin Limited, respectively.