ICTU Systems Development Manager

2 weeks ago

London, United Kingdom Imperial College London Full time

Are you an expert in clinical trial Data Systems and Data Management? We are looking for a new Systems Development Manager of Clinical Data Systems (CDS) to join team, to provide overall responsibility for all stages within the Electronic Data Capture (EDC) lifecycle across a variety of different studies, phases and therapeutic areas.

The Imperial Clinical Trials Unit (ICTU) brings together academic, clinical and trial management expertise from across the Imperial College Academic Health Science Centre (IC AHSC) to deliver world class clinical trials of all phases and designs. The remit of the Clinical Data Systems (CDS) team is to provide development and support of an EDC system for studies undertaken in ICTU and researchers College wide.


As Systems Development manager, you will:

Ensure that the design, development and testing solutions delivered are both fit for purpose and compliant with regulatory requirements and delivered within strict timelines.Provide overall responsibility for all stages within the EDC lifecycle from eCRF design, development and testing based on user requirement specifications to Go-Live for a study across a variety of different studies, phases and therapeutic areas.Provide expert advice in eCRF design and development based on clinical protocols / requirements specifications ensuring appropriate design and development activities are undertaken for each developed trial prior to Go-Live, to demonstrate stability, performance and fitness for purpose.Be a lead point of contact with the trial teams, project managing the development and testing aspects of the eCRF development through the development life cycle, to ensure timelines for completed trial database design are met.Translate the requirements into trial design specifications and author, design and develop eCRF and Edit Checks for EDC (Electronic Data Capture).Identify, continuously develop and execute the appropriate activities to ensure compliance with Good Clinical Practice (GCP) regulations, regarding the eCRF development and testing with the OpenClinica v4.0 EDC ensuring that standards and methodologies are followed.

A full list of essential and desirable criteria can be found in the Job Description and Person Specification.

You will be expected to demonstrate the following:

A degree or equivalent in computer science or a relevant subject and/or relevant experiencePrevious experience gained working within a Pharmaceutical, CRO, Biotech company or a Clinical Trials unit.Team management experiencePrevious experience with OpenClinica or other trial development/ EDC systems.Proven technical experience of eCRF design/ development using and EDC design/development tool.

This post is full-time and open-ended. You will be based at Stadium House, Wood Lane, close to Wood Lane and White City tube stations.

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