Senior Data Standard Expert

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**:
You will act as reference for Data Collection standards and support the development, maintenance, optimization, and implementation of General and Therapeutic data standards (Clinical Data Collection: CRF and external data sources using Metadata Repository) based on CDISC and industry standards.You will participate in the study protocol review and assess impact on Data Collection standards. You will lead discussions for new content of CRF and collaborate with internal/external stakeholders (e.g. Data Management, Stats/ Programming, PK/PD and Biomarker departments, etc.). Design and update data collection forms.Collaborate with the SDTM team, as well as engaging with cross functional teams on departments initiatives. You will lead process improvement initiatives. Prepare and communicate the standard libraries releases for cross functional teams and external partners and maintain the Standards company eDC library (incl Edit Checks and CRF CG).

Supports defining/maintaining a governance framework for data standards and change and contribute/lead the Governance and Advisory Boards.

**Who you are**:

- BS and or MS with 10-12+ years in data management or standards experience.
- Proven experience in clinical study set-up, CRF design and Edit check programming.
- Proven experience in Data Standards Development and Governance
- Proven experience in development and implementation of Data Management functionalities, tools, workflows, and validation procedures
- Project leadership expertise
- Excellent Knowledge of eDC systems and MDR (Like Formedix)
- Excellent Knowledge of CRF industry standards and CDISC standards
- Excellent understanding of trial activities and drug development, sound understanding of the Global Clinical Development function, as well as understanding of the pharma ethical business and commercial environment

**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life

Job Requisition ID: 258321

Location: Darmstadt

Career Level: D - Professional (4-9 years)

Working time model: full-time

**North America Disclosure**

**Notice on Fraudulent Job Offers**
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.

**Job Segment**:R&D, Clinical Research, Medical Research, Business Process, Research, Healthcare, Management