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Let's push the boundaries together and make the most of your talents!

Head Clinical Data Standards

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  68387

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

 

 

 

 

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)

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

 

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

 

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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