Study Data Lead
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 Clinical Science & Operations (GCSO) department**, based either in **Monheim (Germany), Brussels (Belgium), Raleigh (US) or Slough (UK) **we are looking for a talented individual to fill the position of**:Study Data Lead**
**As a Study Data Lead you will lead the project management and delivery of data management for assigned studies in all aspects of data management including study set-up and oversight. You will play a key role, business partnering with Global stakeholders and acting as a key point of contact for studies.**
**You like to work in an** **environment **where you can**:
- Represent the Study Data team and lead as a key point of contact within the business
- Oversee data management activities including, project management of deliverables and data management planning
- Assess study data risk management, oversee data collection mechanisms, and provide insight on process improvement and solutions when necessary
**You will** contribute** **by**:
- Engaging and collaborating cross-functionally to lead and implement data solutions for the data collection and management of studies
- Collaborating with Asset Data Lead and Standards managers to identify and create required new Standards
- Managing the preparation of assigned study material and documentation, including data flow diagrams, data reconciliation checks, SDTM documentation and IPD specifications
- Managing external vendors including CROs, ensuring data and documentation deliveries are completed adhering to project timelines
- Serving as a Subject Matter Expert (SME) in data management competencies to streamline data management processes, developing Global Training and guidance materials
- Ensuring the delivery of CDI data deliveries according to planned timelines including Coding data, Vendor Data, SDTM data, Raw data and Operational data
- Supporting submissions, audits and inspections as required
**I**nterested? For this position you’ll need the following** **education, experience** **and **skills**:
- Proven track record of Clinical Data management experience and project managing studies
- Proven experience delivering Study Clinical Data Management responsibilities
- Knowledge of federal regulations, Good Clinical Practice and Good Clinical Data Management Practices
- Prior knowledge of computer system validation methods, in particular FDA 21 CFR part 11 desirable
**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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