Clinical Data Standards Lead

작업 내용

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?

As Clinical Data Standards Lead (AD grading), you will manage and contribute to the Clinical Data Standards (CDS) team, which develops data standards focused on clinical data collection and reporting. Standards are created in the UCB Clinical Metadata Repository (CMDR) in CDASH and SDTM formats, driven by protocol requirements and aligned to analysis needs through the UCB End to End (E2E) Data Standards Teams (DST).

Key requirements:

Aligns Clinical Data Standards operations with standards governance model. Executes on UCB’s clinical data collection standards strategy. The scope of standards includes: eCRF, ePRO/eCOA, CRF completion instructions, edit checks, controlled terminologies, SDTM datasets, SDTM mappings and data transfer specifications

Key tasks:

• Contribute to development of the CDS team within organization by identification of training and development needs, providing onboarding, training, coaching and standards project planning and implementation.
• Maintain awareness of external environment including regulation and industry groups to ensure compliance and implement innovation.
• Actively engaging with Business Units and GCSO (clinical) Stakeholders, beginning at project conception, to identify clinical data collection requirements not addressed by existing UCB data standards.
• Developing, updating, and retiring standards in CMDR aligned with the DSTs.
• Making appropriate CMDR standards available for study level builds.
• Managing standards requests and questions through a ticketing and workflow system.
• Updating and maintaining the Standards SharePoint Site to share standards metadata with applicable stakeholders esp. Statistics (Programming), Clinical Teams, CRO partners.
• Being the subject matter expert for company submission requirements regarding (clinical) data standards and participate on external teams as needed e.g. CDISC.

Required education, experience and skills:

• Relevant bachelor’s degree
• 5+ years of experience in the CRO/pharmaceutical industry working in the area of clinical data and its related standards
• 10+ years of experience in a multicultural and global pharmaceutical environment
• Experience in leading, participating on and collaborating with global cross-functional groups effectively in order to reach and negotiate consensus
• Comprehensive knowledge of Good Clinical Practices and international regulations
• Advanced knowledge of the CDISC standards, esp. CDASH, SDTM, controlled terminology, (Define.xml, ODM, ADaM, Biomedical Concepts beneficial)
• Knowledge and understanding of proven and accepted standards development processes.
• Excellent communication skills, with the ability to build strong relationships and exchange information internally across functions and from external sources.
• Highly organized with proven project management and time management skills.
• Excellent communication skills, with the ability to build strong relationships and exchanges information internally across functions and from external sources.
• Ability to adapt to working in a multicultural environment with teams located globally
• Ability to work with limited close supervision
• Proficiency in English, written and verbal

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.

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.