Clinical Systems Analyst (Business Analyst)

UCB S.A.
Durham, NC Full Time
POSTED ON 10/9/2021 CLOSED ON 10/10/2021

What are the responsibilities and job description for the Clinical Systems Analyst (Business Analyst) position at UCB S.A.?

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?


To strengthen our Clinical Data & Innovation team, we are looking for a talented individual to fill the position of: Clinical Systems Analyst (Business Analyst)


As a
Clinical Systems Analyst (Business Analyst), you will be the bridge between clinical study teams and IT experts to ensure that clinical trial technologies meet user expectations, align with regulated processes and enable UCB to deliver on our goal of creating value for people living with severe diseases


You like to work in an environment where you can:

  • Lead the delivery of clinical solutions to collect and manage operational and clinical information within and across studies
  • Collaborate with clinical research specialists and IT experts to enable the successful implementation and ongoing support of clinical applications, processes and data repositories.


You will contribute by:

  • Providing business-focused oversight and management for CDI clinical applications, system integrations, and data repositories. Systems may include:
    • Clinical Trial Management System (CTMS), Reporting and dashboards for CTMS, Electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Thesaurus Management System (TMS), Clinical Metadata Repository (CMDR), Clinical Data Repository (CDR), Electronic Patient Reported Outcomes (ePRO), Clinical Patient Reported Outcomes (ClinPRO), others
  • Overseeing new releases and solution enhancements, and work in collaboration with IT in the System Development Life Cycle (SDLC) from feasibility and gathering requirements, to implementation, training and maintenance
  • Prioritizing IT support, projects, change requests, and supporting the coordination of projects in line with CDI/Global Clinical Sciences & Operations (GCSO) and UCB’s strategy
  • Acting as the Process Data Owner (PDO) in the development, review and approval of system documentation
  • Working with clinical study teams to ensure successful implementation and maintenance of solutions for data collection and management within and across studies
  • Providing reports and dashboards to clinical study teams to identify data issues, deliver study/program metrics, and describe clinical trial operations for multiple audiences
  • Delivering skilled business advice on the selection of new clinical technologies by evaluating new technologies and their potential use for CDI in line with UCB’s overall strategy


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

Minimum Qualifications:

  • Bachelors Degree required
  • 7 years pharmaceutical/CRO setting experience


Preferred Qualifications:

  • At least 5 years relevant experience in the clinical data / technology field in Drug Development or Life Sciences working with EDC, CTMS, TMF, CMDR, CDR, reporting / dashboards, system integrations, and other clinical systems
  • 5 years GxP and system validation experience
  • Knowledge of clinical processes and technical framework
  • Previous experience creating new processes, SOPs and related documents
  • Knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices


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.


UCB is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


Where permitted, applicants for employment in the United States must either have received or be willing to receive a full COVID-19 vaccination by the date of hire; or, alternatively, agree to be subject to weekly COVID-19 testing, subject to religious and medical exemptions and in accordance with applicable law.

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