Description Position Details Birmingham Clinical Trials Unit, School of Health Sciences, College of Medicine and Health Location: University of Birmingham, Edgbaston, Birmingham UK Full time starting salary is normally in the range £46,485 to £55,295 with potential progression once in post to £62,098 Grade: 8 Full Time, Fixed Term contract up to two years Closing date: 9th January 2025 Our offer to you People are at the heart of what we are and do. The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years, and we are equally proud to be recognised as a leading global university. We want to attract talented people from across the city and beyond, support them to succeed, and celebrate their success. We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. With almost 5,000 professional services jobs in a wide-range of functions in Edgbaston and in our campus in Dubai, there are plenty of opportunities for you to be able to develop your career at the University. We believe there is no such thing as a typical member of staff and that diversity is a source of strength that underpins the exchange of ideas, innovation, and debate. We warmly welcome people from all backgrounds and are committed to fostering an inclusive environment where diversity is at the heart of who and what we are, and how we work. Supporting our people to achieve a healthy work/life balance is important both to our employees and to the success of the University and, depending on the role, we offer a variety of flexible working arrangements. We therefore welcome discussions on all forms of flexible working. In addition, you will receive a generous package of benefits including 40 days paid holiday a year, one paid day a year for volunteering, occupational sick pay, and a pension scheme. We also have three high quality subsidised day nurseries. The University is situated in leafy Edgbaston and there are excellent transport links to our beautiful campus, including main bus routes and a train station on site. On campus we have a state-of-the-art sports centre with pool, shops, places to eat and drink, our own art gallery, museum and botanical gardens. Find out more about the benefits of working for the University of Birmingham Role Summary The role of the post is to lead a team of analyst programmers responsible for the development, oversight and maintenance of Clinical Trial Management Systems. The post holder will apply their specialist knowledge of data systems and programming to lead and inspire the programming team to deliver programming tasks to time, target and budget, to create and maintain the requisite quality standards and generate and maintain all required documentation, including specification versions, programming and validation efforts, in support of database build and maintenance. A key function will be to lead on the development and design of novel and bespoke systems, as required, to continue to progress technology and ensure delivery of effective clinical trial databases. They will be responsible for all aspects of staff development and management and will plan and monitor staff resource within their team. They will advise stakeholders on all elements of capturing, managing and extracting their data. They will deliver teaching and training to team members and other stakeholders as appropriate and contribute to the operation of the Unit by representing the programming team on Committees/working groups etc. (internal and external) and take an active role in developing the Unit’s Quality Management System (QMS). This is an exciting opportunity for a senior lead programmer who already has experience in clinical trials or for someone would like to build on the strength of their current experience and pursue a leadership role in the development of clinical trial data capture systems. We would welcome informal enquires from individuals who may want to discuss current experience and relevance to this role prior to applying. Main Duties Lead a programming team responsible for the provision and maintenance of clinical trial management systems and create strategies for future direction of database provision in the BCTU. Report directly to the Unit Director of Operations and liaise with the Unit Director and other BCTU Team Leaders. Work independently but seek appropriate guidance on important or new issues that require an overview or policy decision or have serious resource implications, or which could impact on the work of other teams or affect the Unit’s external profile. Develop their team’s capacity to provide software solutions required by or useful to the Unit. Provide specialist advice to Investigators/collaborators, statisticians and trial management staff on data collection tools and protocol design issues that impact on the delivery of clinical trial management systems. Prioritise software projects in liaison with the Unit’s senior management and trial team leads. Ensure milestones are met and projects are where possible delivered to time and target. Advise the Unit Director of Operations of potential issues which may affect delivery, and advise on and implement corrective actions. Oversee the teams software projects ensuring that the work is carried out in accordance with the applicable (inter)national regulations and quality standards, University of Birmingham and Unit procedures and external contracts/agreements. Supervise the management of projects delegated to the analyst programmers, providing instruction, advice and guidance as necessary and providing innovative solutions to problems as appropriate. Review and sign off system documentation. Where appropriate act as a member of individual Trial Management Group(s). Monitor progress of the research projects keeping records of and dealing with any issues. Be responsible for the (line) management of the programming team with respect to day-to day supervision and motivation of staff (including work allocation, monitoring performance and time keeping). Be responsible for the recruitment and training needs of the team, this will include taking part in the selection and appraisal processes, setting and overseeing training plans. Ensure staff are appropriately trained to undertake their duties; including providing mentorship, coaching, one-to-one training, tutorials, setting, overseeing and signing off training plans. Oversee performance and conduct staff development reviews. Assist trial management team leads with planning the financial and resource requirements for trial computer systems. Represent the Unit at (inter)national meetings. Contribute to working parties/committees at a local and (inter)national level including acting as members of University of Birmingham clinical trials committees/groups. Contribute to local and (inter)national trial management initiatives. Act as a member of the Unit’s Senior Management Team, provide oversight, report progress, issues or potential problems to the Unit Director of Operations. Communicate policy and decisions positively to staff. Assist and on occasion take a lead on the preparation of Unit reports. Actively contribute to the Unit’s QMS. Develop expert knowledge in relevant areas of clinical trial management systems. Write policies, standard operating procedures and quality control documents. Take an active role in training staff. Positively promote the QMS and ensure team compliance. Keep up to date with changes in software development methodology, clinical trial methodology, and regulatory issues and develop strategies for future direction of data capture and management systems. Help ensure that new skills, knowledge and best practice are disseminated to the programming team. Conduct software projects in accordance with the principles of Good Clinical Practice (GCP) with specific reference to data integrity and computer system validation requirements and also ensure adherence to applicable NHS Trust and University policies and procedures, (including, but not limited to the University’s Data Protection Policy, Information Security Policy and Code of Practice for Research). Undertake other tasks as applicable to the role and grade of the post. Required Knowledge, Skills, Qualifications, Experience Strong multi-threaded programming skills. Graduate (higher degree preferred) in a relevant computer science subject with strong experience in a senior role and an understanding of clinical trial database requirements. An in-depth understanding of: Relational databases; Expert understanding of C#, ASP.NET, SQL programming, Microsoft SQL programming, Microsoft SQL Server database design and administration; Web application development, continuous integration and ability to appraise “off the shelf systems”; Microsoft operating systems and network environments; Regulations and guidance governing clinical trials in the UK and trial management methodology is desirable but not essential; Proven ability to manage software development projects, covering all steps from initial specification, design, implementation, testing, deployment, change management and closure. Experience of writing trial system documentation and reports essential. Experience of contributing to data collection tool design. Ability to define policy and procedure. Proven administrative and project management skills. Proven ability to supervise, mentor, train and manage staff; including recruitment and appraisals. Office management skills. Ability to work to an extremely high level, with periods of intense concentration, dealing with interruptions as they arise, which may require a change of focus for urgent issues. Able to work on own initiative and problem solve while constantly prioritising work of self and others. Proven ability to multitask. Excellent communication, negotiation, presentation and inter-personal skills. Must demonstrate a critical and intelligent attention to detail and high standards of accuracy. Ability to meet the travel needs of the post nationally and internationally on occasion. Further particulars can be found here Informal enquiries to Margaret Grant, email: m.r.grantbham.ac.uk View our staff values and behaviours here We believe there is no such thing as a 'typical' member of University of Birmingham staff and that diversity in its many forms is a strength that underpins the exchange of ideas, innovation and debate at the heart of University life. We are committed to proactively addressing the barriers experienced by some groups in our community and are proud to hold Athena SWAN, Race Equality Charter and Disability Confident accreditations. We have an Equality Diversity and Inclusion Centre that focuses on continuously improving the University as a fair and inclusive place to work where everyone has the opportunity to succeed. We are also committed to sustainability, which is one of our values. You can find out more about our work to create a fairer university for everyone on our website .