Senior Clinical Data Standards Developer (Denmark, Søborg)

Novo Nordisk A/S; Søborg; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk A/S i Søborg søger en erfaren Senior Standards Developer i Data Standards-området. Du får en central rolle i at sikre ensartet anvendelse af kliniske data standarder på tværs af kliniske udviklingsprojekter og bidrager til governance, udvikling og implementering af standarder.

Du arbejder tæt med funktioner som Clinical Data Management, Trial Management og Biostatistics og får mulighed for at påvirke metadata, CRFs og Controlled Terminology gennem hele den kliniske livscyklus.

Qualifications

• Krav om erfaring med kliniske data og dataadfærds-standarder.
• Gerne kendskab til SDTM, CRF design og controlled terminology.
• Stærke kommunikationsevner og tværfagligt samarbejde.
• Forståelse for GxP og kliniske dataflow fra indsamling til analyse og indsendelse.

Responsibilities

• Udvikle, vedligeholde og implementere kliniske data standarder i kliniske udviklingsprojekter.
• Understøtte styring og operationel kontrol af standarder, CRFs og Controlled Terminology.
• Bidrage til specifikation og implementering af end-to-end data standarder og relateret metadata.
• Fortolke kliniske studieprotokoller for korrekt adoption af data standarder.
• Samarbejde på tværs af funktioner for at drive standardisering og overensstemmelse.

Skills

Clinical data standards

Cross-functional collaboration

Clear communication

GxP knowledge

Education

Life sciences / clinical data management background

Tools

EDC systems

Metadata repositories

Job description

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Data & AI

Data Standards Enablement
Søborg, Aalborg/Denmark or Bangalore/India

Are you passionate about clinical data standards?
Do you want to help shape how clinical data is collected, standardized, and used across global development programmers? Are you motivated by working at the intersection of clinical trials, metadata, regulatory requirements, and digital solutions?

If so, you could be our next Senior Standards Developer in Data Standards.

Your New Role
As a Senior Standards Developer, you will play a key role in ensuring the consistent, end-to-end use of clinical data standards across Novo Nordisk clinical development projects. You will contribute to the governance, development, implementation, and continuous improvement of clinical data standards, helping to support compliant, efficient, and high-quality study execution across the organization.

In this role, you will:

• Develop, maintain, and implement clinical data standards across clinical development projects.
• Support the governance and operational control of standards, including CRFs and Controlled Terminology.
• Contribute to the specification and implementation of end-to-end mapped clinical data standards and related metadata.
• Interpret clinical trial designs and protocols to support the accurate adoption of data standards.
• Collaborate across Clinical Data Management, Trial Management, Biostatistics, Statistical Programming, Clinical Operations, and other relevant functions to drive standardization, compliance, and innovation.

You will also work with clinical metadata in relevant systems, including metadata repositories, ensuring standards are accurately captured, maintained, and available for downstream use throughout the clinical development lifecycle.

Your New Department
Data Standards is responsible for enabling consistent, high-quality clinical data collection and standardization across clinical development. We work closely with stakeholders across the clinical trial value chain to deliver scalable standards, support efficient study execution, and contribute to robust regulatory submissions.

You will join Data Standards Enablement, a team of approximately 10 colleagues within the broader Data Standards organization of approximately 20 people. The team is characterized by strong stakeholder engagement, a collaborative mindset, and a commitment to continuous improvement and the future of clinical data standards.

Your Skills and Qualifications
To succeed in this role, we imagine that you bring a combination of clinical trial understanding, data standards knowledge, and strong collaboration skills.

We are looking for someone with:

• A relevant educational background within life sciences, clinical information management, pharmacy, nursing, medicine, veterinary science, computer science, or a comparable field.
• Preferably 5+ years of experience in clinical data management, trial management, statistical programming, clinical operations, or another relevant clinical development discipline.
• A good understanding of clinical trial conduct, GxP requirements, and the clinical data flow from data collection through analysis and submission.
• Knowledge of clinical data standards, CRF design, Controlled Terminology, SDTM, and/or metadata-driven clinical systems.
• Strong communication skills, a structured and quality-focused approach, and the ability to collaborate effectively across functions, cultures, and organizational levels.

Experience with metadata repositories, standards libraries, EDC systems, or related clinical systems will be considered an advantage.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer
At Novo Nordisk, you'll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary: For this role, the Annual Base Salary ranges from 651,000.00 to 956,900.00 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here

Deadline: 7 September.

Please note that applications will be reviewed on an ongoing basis.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.