Please note, this vacancy is open to current University of Glasgow employees only 

Job Purpose

The Senior Software Application Developer at the Robertson Centre for Biostatistics, part of the Glasgow Clinical Trials Unit, will be responsible for the provision of specialist knowledge and expertise, leading software development for clinical trials and research studies, with a focus on complex systems such as randomisation, drug supply management, and safety reporting. The role involves ensuring high-quality technical delivery, compliance with ISO 9001, ISO 27001, and Good Clinical Practice, and driving process improvement. The postholder will work independently on software development activities and support the Head of Data and Applications in leading a clinical trials IT provision of excellence.

This senior position requires both technical expertise and strategic oversight, using initiative to drive quality and process improvement, ensuring compliance with legislative requirements, to shape and ensure delivery of effective clinical trial software solutions. The successful candidate will establish effective collaborative relationships with senior programmers, data managers and other key stakeholders in driving innovation, staying current with emerging technologies to enhance team capabilities and maintain high standards in a clinical research environment.

Main Duties and Responsibilities

1.      Lead the development and management of complex, leading-edge clinical trial software applications, including implementation of electronic data capture (EDC) provision, computer systems validation, API interfacing and integration with external data research systems, for use by commercial clients, clinical researchers, and internal users, ensuring robust project management and exceptional quality standards.

2.      Provide support, leadership and direction in the area of software development by working with senior management to determine priorities, establish robust delivery schedules and monitor progress, contributing to the software development function within Data Management at a senior level to ensure current and future research requirements are met.

3.      Drive technical excellence and innovation through developing new techniques and approaches for enhanced technical solutions, building and maintaining robust software infrastructure, with responsibility for the architectural and security related aspects of the design and implementation, adapting to changing technologies, ensuring system availability, confidentiality, and integrity, and leading code reviews and quality control activities.

4.      Lead excellent interfacing with the wider data management function, including improvements in API integrations, data collection and validation solutions, with strong commitment to supporting process improvements leading to provision of high quality data in a clinical trials context.  Additionally, promote excellence across clinical trials teams by contributing at a senior level to cross-functional communications and improvements, leading to an overall excellence in clinical trials management.

5.      Contribute to maintaining excellent stakeholder relationships and communication for software development activities by developing and maintaining excellent working relationships with colleagues, external clients, and study sponsors, ensuring completion of work to high-quality standards within strict client and regulatory timelines.

6.      Make a leading contribution to quality management processes including production and review of standard operating procedures, participation in regulatory audits and inspections, ensuring adherence to ISO 9001, ISO 27001, computer systems validation, Good Clinical Practice, and data protection regulations, and contributing to contractual agreements and regulatory review documents.

7.      Demonstrate leadership in identifying, defining and effectively implementing key process improvements in the delivery of efficient and high-quality clinical trial software solutions in support of world-class clinical research. Manage change in a positive, knowledgeable and supportive way, working collaboratively to strengthen cross-functional processes, systems and interactions, generating ideas and solutions with broad and beneficial impact.

8.      Provide senior management, clients, collaborators and other stakeholders with regular updates and briefings to ensure that they have a clear understanding of status and any emerging risks or issues.

9.      Support research and development activities by contributing to research and funding proposals, providing appropriate input to resource and costing preparation.

10.   Contribute to the enhancement of the University’s national and international research profile in line with the University’s strategic plan by leading in the provision of clinical trials data collection and management strategies, in the provision of high-quality data for clinical trials analysis, study reporting and publication in peer-reviewed journals.

11.   Provide technical leadership and mentoring to the software development team by establishing best practices in software development, conducting regular knowledge sharing sessions, leading code reviews, and creating opportunities for team skill development. Maintain current knowledge of emerging software development techniques, frameworks and tools, actively sharing insights and implementing appropriate new approaches to enhance team capabilities and project delivery.

12.   Engage in professional development to stay current with emerging technologies and best practices in clinical research technology.

13.   The duties outlined are not exhaustive and the post-holder will be expected to be cooperative and flexible, undertaking such duties as may reasonably be expected by management. The duties of the post will be subject to review in line with changing requirements, both internal and external.

Knowledge, Qualifications, Skills and Experience

Knowledge/Qualifications

Essential

A1 Qualified in IT to degree level and/or with postgraduate qualification in IT discipline or equivalent, or with broad range of equivalent professional experience

A2 Advanced expertise of software application programming of specialist complex components in a clinical trials context (e.g. safety reporting, endpoints co-ordination).

A3 Extensive knowledge of all areas of clinical trials data management, including data management models involving data collection standards, validations programming and complex API interfacing of bespoke specialist components.

A4 Extensive knowledge of technical SQL programming, web development and .NET programming

A5 Strong knowledge of the requirements of ICH Good Clinical Practice and all other legal and regulatory requirements in the management and co-ordination of clinical trials.

Skills

Essential

C1 Specialist skills and expertise in the area of software application programming and clinical trials data management in an IT environment

C2 Effective planning skills and proven delivery of complex software applications

C3 Strong user-focussed approach with ability to understand and present complicated technical information in an easy-to-understand format

C4 Ability to cope under pressure while maintaining a high level of accuracy, with ability to work independently, assess priorities and manage own workload effectively

C5 Excellent interpersonal skills and ability to work as part of a team with staff at all levels

C6 Reliable, trustworthy and able to maintain confidentiality

C7 Exceptional ability to develop skills in response to technological change, particularly in clinical data management and software development

Experience

Essential

E1 Substantial relevant experience at an appropriate level, demonstrating extensive ability and knowledge in clinical trials software development and data management

E2 Significant experience of .NET, SQL programming, API and web development

E3 Extensive experience at an appropriate level of undertaking full project lifecycle software development activities and producing appropriate requirements, design and testing documentation

E4 Experience in training, mentoring and supporting junior staff

Terms and Conditions

Salary will be Grade 8, £49,250 - £56,921 per annum.

This post is full time and open ended.

The University of Glasgow has a responsibility to ensure that all employees are eligible to live and work in the UK.  If you require a Skilled Worker visa to work in the UK, you will be required to meet the eligibility requirements of the visa route to be assigned a Certificate of Sponsorship.

Please note that this post may be eligible to be sponsored under the Skilled Worker visa route if tradeable points can be used under the Skilled Worker visa rules. For more information please visit: https://www.gov.uk/skilled-worker-visa.

Closing date: 23:45 on Thursday 20th February 2025