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Standards Curator

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  65971

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 Clinical Data and Innovations Team, based in our US, UK, Germany or Belguim Offices, we are looking for a talented individual to fill the position of: Standards Curator.

As a Standards Curator you will Ensures compliance to defined industry and UCB data standards throughout the case report form (CRF), eCRF, and annotation development process.

 

You will contribute by:

  • Coordinates timely (clinical) data standards development and maintenance to ensure consistent acquisition and reporting of (clinical study) data.
  • Provides support for the (clinical) data standards technical architecture.
  • Manages cross-functional teams and project teams.
  • Ensures adherence to UCB (clinical) data standards by reviewing / approving CRF development by CRO Partners including oversight of (clinical) study database build activities
  • Participates in study team or review meetings as necessary to assess (clinical) data acquisition / collection requirements of the clinical study as needed
  • Actively engages with Patient Value Unit (PVU) Stakeholders beginning at project conception to identify (clinical) data acquisition / collection requirements not addressed by existing UCB data standards.
  • Manages (clinical) data standards development for project teams (e.g., by asset / indication / therapeutic area)
  • Works with project / study teams to develop new standard Core CRF Modules (CCMs) and Project-Specific CRF Modules (PSCMs) in collaboration with the Data Acquisition and Reporting Committee (DARC)
  • May serve as member / chair of the DARC and support meeting coordination and communication needs.
  • Creates and maintains the (Clinical) Metadata Repository (MDR); Clinical Outcome Assessment Repository (COAR); related SharePoint Sites; etc. to ensure consistent information regarding the UCB standards is readily available to applicable stakeholders esp. CRO partners
  • Acts as point of contact for (clinical) data standards maintenance when needed.
  • Subject matter expert for company submission requirements regarding (clinical) data standards.
  • Promotes (clinical) data standards ownership across departments and functions.
  • Participates on CDISC, TransCelerate, HL7, and other external teams as needed.
  • Provides training as needed to internal and external stakeholders
  • Other responsibilities and projects the Company may assign.

 

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

    Minimum Qualifications:

  • Bachelor’s Degree
  • 7+ years of experience in the CRO/pharmaceutical industry working in the area of clinical data and its related standards
  • 5+ years of experience in a multicultural and global pharmaceutical environment.
  • Advanced use of MS Office suite of products and Adobe Writer.
  • Comprehensive knowledge of Good Clinical Practices and international regulations.
  • Experience managing global cross-functional groups effectively in order to reach consensus.

 

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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