Study Data Risk Manager
il y a 4 jours
**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 **Global Study Data Risk Management Team**, based **in Belgium, Germany** or Raleigh (US)**, we are looking for a talented individual to fill the position of **(Associate) Study Data Risk Manager**:
**The** **Study Data Risk Manager (SDRM) **will develop and execute Data Surveillance (DS) strategy oversight of a clinical trial. You play a pivotal role in leading the definition and execution of the Data Surveillance Oversight plan. This includes setting and monitoring Quality Tolerance Limits (QTL) data reviews and oversight of contract research organisation data surveillance activities. You will investigate potential trends, issue and risk at site or study level, assisting with study risk assessment and the definition of critical data and processes. This role will give you the opportunity to enhance your skills by involvement in specialised projects and the potential to gain experience within the wider data organisation.**
**You like to work in an** **environment **where you can contribute to the following**:
- Pro-actively identify key risks, critical data and critical processes to contribute to the development of the cross-functional risk mitigation plan based upon protocol summary, protocol and other pertinent key documents.
- Identify Data Surveillance Oversight strategy for a trial and develop/assist in study Data Surveillance Oversight Plans (DSOP) based on study characteristics and risk register. This includes:
- Identification of the study-specific areas of interests to be monitored and identification of the required data to enable risk management analysis
- Identification of the process with the CRO for the escalation of both UCB and CRO
- Data Surveillance findings and identification/follow-up of mitigation actions.
- Execute DSOP including QTLs settings, monitoring, data surveillance oversight, functional spotchecks and study specific data reviews
- Participate in and actively contribute to meetings to discuss study, site, and patient level trends and identify potential risks and issues
- Serve as lead change agent within study teams to embed risk-based and central statistical monitoring within the organization
- Contribute to the development/improvement of relevant processes, sops, tools, analytics, and training for centralized risk monitoring.
- Provide guidance to less-experienced Study Data Risk Managers
- Support in review study budget with high-level supervision of line manager or senior SDRM
**Your experience and requirements**:
- Prior experience within a pharmaceutical research and development environment or allied field within clinical study management
- As a lead position, you will be required to have worked in a similar data quality or clinical data surveillance/centralized monitoring position
- Experience in Centralized Monitoring tools and/or data visualization tools (e.g Spotfire, QlikSense)
- Working practice and knowledge around medical terminology, governance regulations and good clinical practice
- Ability to collaborative effectively within a cross functional matrix environment
- Excellent communication skills both written and verbal
- Solution orientated mindset and ability to evaluate processes, gather facts and data and determine mitigatory actions
**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 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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