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AIXIAL Group is an international Contract Research Organization (CRO), a part of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden, UK, Romania, US, and Czech Republic.
The AIXIAL Group occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials for immuno-oncology and cell & gene therapies, but also as a developer of its own game-changing EDC and eSource platform encapsia for managing clinical data.
This is a very exciting time to join Clinical Data Management as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data and we are now looking for talented
**The Role**:
You will provide leadership for clinical data management tasks and be responsible for the delivery of multiple, large or complex projects. Depending on your skills and experience, there are opportunities for specializing in certain data management aspects (e.g. risk-based approaches, Real-World Data), providing client/program oversight, and mentoring junior team members.
This role can be remote anywhere in the UK or EU, or (partly) office based.
**This role could be perfect for you if you**:
Have extensive clinical data management experience in an ICH/GCP environment
Have led large or complex global oncology studies, ideally within a Contract Research Organization (CRO)
Have hands-on experience in all end-to-end clinical data management activities, including eCRF design / UAT, third-party vendor management, (central) data review and close-out
Have experience with defining data strategies and data flows for complex trials involving multiple data sources (incl. central lab, eCOA/ePRO, IxRS)
Understand data structures e.g., CDISC CDASH and STDM
Have significant experience using data reporting and/or review tools, and creating programming specifications
Are an excellent communicator and have experience working with global, cross functional teams and having direct client and vendor interactions
Have proactively managed project budgets, timelines, and resources
Are great at planning, well organised and can work calmly under pressure
**What we offer**:
A dynamic, friendly, and supportive team
Innovative and exciting technologies
Mentorship and training to further develop your skills
Home or office-based location
Competitive compensation package
