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

Database Delivery & Oversight Lead

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  68226

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 in our RTP Office in Raleigh, NC, we are looking for a talented individual to fill the position of: Database Delivery and Oversight Lead.

 

The Database Delivery & Oversight Lead is responsible for building a study eCRF in UCB metadata repository system, defining structure of datasets that are part of data transfer specification as well as ensuring quality and completeness of SDTM format data.

 

You like to work in an environment where you can:

  • Based on information provided by the Study Data Lead using standard libraries existing in metadata repository create study level deliverables:
    • Basic eCRF including forms, form instructions, controlled terminologies edit checks, e-mail alerts etc
    • Data transfer specification dataset structures for clinical data collected outside of eCRF (e.g. central laboratory, eCOA etc)
    • SDTM datasets and RAW to SDTM mappings 
  • Collaborate with UCB colleagues and CRO Partners to finalize the design, creation and implementation of EDC solutions

 

You will contribute by:

  • In collaboration with Study Data Leads ensuring the planning for data receipt and its oversight throughout the duration of assigned clinical trials
  • Processing data loads from various sources into the clinical and operational data repositories including the review and communication of issues.
  • Programming reports and contributing to the standardization of process and reports used for data review and analysis for external partners/vendors and internal UCB
  • Completing formal and ad-hoc analyses and oversight of SDTM data.
  • Reviewing critical document/deliverable (SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of DE dataset

 

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

  • Relevant academic background
  • At least 5 years relevant experience in relational database design
  • 2-3 years SAS experience preferred
  • Experience with Data Management processes, to include:
    • Review of SDTM annotated CRFs
    • Writing and reviewing technical specifications
    • Review of log files for errors and warnings
  • Experience with data mapping and SDTM Controlled Terminology
  • Prior experience in a clinical or pharmaceutical related as well as Data Management field is required.
  • Experience with relational databases, preferably Clinical Data Management and EDC Systems
  • Advanced familiarity with reporting tools.
  • Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.

 

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.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

 

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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