Director / Associate Director, Clinical Systems

20 hours ago


Horsham, United Kingdom Cmed Full time

The AIXIAL Group is an International Contract Research Organization (CRO), a member 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, US, Romania and Czech Republic.

The CRO 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 technologies for managing clinical data.

We are currently looking for an enthusiastic and talented Director / Associate Director, CRO Systems. This role can be home-based anywhere in the UK or EU (where we have the legal entity to hire).

Purpose of Role

The Director / Associate Director, CRO Systems will be responsible for the development, delivery and on-going management of the CRO’s clinical systems.

You will ensure delivery and development of the CRO System team against key metrics, and work with Senior Managers to develop and grow capabilities, productivity, and quality.

**Responsibilities**:
Manage a global team accountable for the design, maintenance and support of clinical systems and associated processes, including but not limited to:
Clinical Data Management Systems, including encapsia, Medidata Rave and Viedoc

Trial Master File systems (eTMF), including Wingspan and Veeva eTMF

Clinical Trial Management Systems (CTMS), including Veeva CTMS

Clinical Reporting systems

Pharmacovigilance systems

Contribute to the strategic clinical systems roadmap for the CRO and ensure clinical systems support business processes

Proactively identify areas which would benefit from new systems and technology by maintaining awareness of industry trends and regulatory changes worldwide in Good Clinical Practice and emerging clinical study and real world evidences approaches.

Lead delivery of innovative technology to enable clinical studies and analysis while continuously improving operational efficiency

Develop business cases for new technologies or changes to existing systems which have a clear return on investment

Ensure adherence to internal and external computer system validation requirements

Ensure team is collaborating with business process owners and vendors to identify future enhancements to be included in the product roadmap.

**What we offer**:
A dynamic, friendly and supportive team

Mentorship and training to further develop your skills

Well-designed induction/onboarding program

Competitive compensation package

Home or office-based location


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