Head Clinical Data Standards

vor 3 Wochen

Monheim, Deutschland UCB S.A. Vollzeit

**Make your mark for patients.**

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our **Global Clinical Science & Operations (GCSO) department**, based either in **Monheim (Germany), Brussels (Belgium), Slough (UK) or Raleigh (US)** we are looking for a talented individual to fill the position of**:Head Clinical Data Standards**

**As Head of Clinical Data Standards you will be responsible for the development, maintenance and adherence to UCB’s clinical data standards including eCRF (forms, edit checks, controlled terminologies etc.,) data transfer agreements for clinical studies, SDTM and SDTM mappings. The role coordinates/contributes to wider Development Solutions data standards leadership and governance as well end-to-end automation of clinical data flow.**

**You like to work in an **environment** where you can**:

- Oversee the development, maintenance and adherence to UCB’s clinical data standards and documentation
- Lead a global team managing standards and ensuring external intelligence and collaboration is incorporated into UCB’s practices

**You will **contribute** by**:

- Overseeing the process and technology used to store standards and automate the end to end clinical data flow
- Engaging internal and any external stakeholders to ensure awareness, understanding and alignment related to Data Standards and their associated benefits and processes/requirements/dependencies.
- Pro-actively engaging external forums to identify opportunities and best practices and standards to implement within UCB
- Supports efforts to integrate and harmonize activities across multiple sites with an emphasis on team spirit, work style, consistent processes and technology

**Interested? For this position you’ll need the following **education, experience** and **skills**:

- Relevant academic background
- 10+ years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation
- 5+ years of experience in the CRO/pharmaceutical environment related to the development/implementation of (clinical) Data Standards, esp. CDISC
- 3+ years of line management experience in a CRO/pharmaceutical environment with a successful record of developing personnel and teams
- Thorough knowledge and understanding of standards development processes, esp. for clinical data
- Comprehensive knowledge of Standards Data Organizations (SDOs) and ability to utilize their resources to gain value for UCB
- Strong knowledge of CDISC, HL7, and ISO standards
- Exceptional communication skills in English (verbal and in writing)

**About us.**

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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