At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
Slough, UK or Brussels, Belgium
Help us transform patients’ lives.
At UCB, we put our heart, soul and skills into making a difference for people living with chronic disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
Headquartered in Brussels, Belgium, is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. UCB operates in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels
To strengthen our Risk Based Monitoring and Standards Team, we are looking to fill the position of Standards Curator
About the Role
You will be responsible for the overall compliance to industry (CDISC, HL7, etc.) and UCB data standards throughout the case report form (eCRF) and annotation development process. As well as coordinate clinical data standards development and maintenance, ensuring consistent acquisition and reporting of clinical study data.
Provide support to the clinical data standards technical architecture and manage cross-functional teams and project teams.
- Review and approve eCRF development by CRO Partners including oversight of clinical study database build activities. Participate in study team and review meetings to assess clinical data acquisition and collection requirements of the clinical study.
- Engage with Patient Value Unit stakeholders beginning at project conception to identify clinical data acquisition and collection requirements. Manage clinical data standards development for project teams by asset, indication and therapeutic area
- Work with project and study teams to develop new standard Core CRF Modules and Project-Specific CRF Modules in collaboration with the Data Acquisition and Reporting Committee and potentially serve as member or chair of the DARC and support meeting coordination and communication needs.
- Create and maintain the Clinical Metadata Repository, Clinical Outcome Assessment Repository and related libraries to ensure consistent information regarding the UCB clinical data standards is readily available to stakeholders
- Act as point of contact for clinical data standards maintenance, be a subject matter expert for company submission requirements regarding clinical data standards. Promote clinical data standards ownership across departments and functions. And participate on CDISC, TransCelerate, HL7, and other external teams.
- Provide training, mentoring, and guidance to other Standards Curators, internal and external stakeholders and assist with resource planning and allocation
- Have a Bachelor’s degree or the equivalent
- Extensive knowledge in the CDISC suite of standards, esp. SDTM, controlled terminology, ADaM, as well as MS Office suite of products and Adobe Writer. As well as relational clinical databases and SAS
- Substantial experience in the CRO or pharmaceutical industry in a global, multicultural environment, in clinical data and related standards
- Comprehensive knowledge of Good Clinical Practices and international regulations
- Experience in line management or mentoring and training. As well as managing global cross-functional groups effectively to reach consensus
At UCB, growth and profitability constitute a guarantee for stability. You will always have the time and the backing needed to turn your ideas into reality. You can plan your future.
We are building the next generation biopharma leader and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, and who want to make a difference and deliver results
At UCB human talent is the greatest asset of our organization – we continue to strengthen our talent pool, our organization and, our ability to deliver.
Interested? You can find out more about the organization at the company’s web site: www.ucb.com.
UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system.
With more than 7500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive. Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB.
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