Design, Development, Validation, Documentation, Maintenance and Support of Custom-Built

Job Profile
Job Description /
Job Details
Job Title: / Clinical Trials Applications Developer - System Administrator
School/Dept/Institute & Centre: / SMD •Blizard Institute •PCTU
Reports to: / Head of Information Systems and Data Management (HISDM)
Grade: / 4 PRO / Full Time
Appointment period: / 2 years
Current Location: / Whitechapel
Job Context
The Pragmatic Clinical Trials Unit (PCTU) situated within the Centre for Primary Care and Public Health and linked with the Centre for Psychiatry leads and supports clinical trials in which the primary question of interest relates to intervention effectiveness: whether an intervention works under real-life conditions. It also carries out and supports pilot studies for these trials. The unit focuses particularly on trials of complex interventions. In addition, staffs carry out methodological research relevant to the unit’s focus. The aim of the unit is to lead, support and encourage high quality pragmatic trials and pilot studies where they fit with the research strategies of the two centres with which the unit is linked, or with the methodological interests of the unit.
Job Purpose
This role is for a multi-skilled Database/Web developer with skills in systems administration to support the maintenance of application servers in liaison with Central IT who host those servers.

Design, development, validation, documentation, maintenance and support of custom-built web-based applications using the latest Web development technologies available.
Maintenance and support of current applications and systems which mainly use Java, PHP and Python-based Web technologies with databases such as MySQL, Postgres and Oracle.
Development of custom web services as required to support the integration of clinical research applications including EDC systems (e.g. OpenClinica, RedCap)
Provision of system administration support in liaison with Central IT to help maintain dedicated PCTU application servers and other systems supporting clinical research.

Main Duties & Responsibilities
Database/Web development and Server Maintenance

Gather requirements, design, develop, Validate/Test, document, maintain and support of secure web-based applications using the latest Web development technologies available.
Support of current applications and systems which mainly use technologies including Java, PHP and Python-based frameworks with databases such as MySQL, Postgres, Oracle.
Development of custom database reporting tools or web services for application integration, as required for existing EDC systems (e.g. OpenClinica, RedCap) or custom-built systems.
Provision of system administration (maintenance of database systems such as MySQL/PostgreSQL/etc., maintenance of application servers such as Apache and other server-side software, deployment of Web applications) for various servers hosting PCTU clinical research applications, in liaison with Central IT. Most servers run on Windows or Linux operating systems.
In liaison with Central IT, ensure that the security of all applications and systems is up to date.
Develop appropriate procedures and documentation as required for database development and maintenance of servers.
To provide end-user training and continuous support as required
To prepare database extracts and reports as needed and work closely with other teams to support data cleaning, query management and statistical analysis.
To regularly monitor compliance with PCTU and database development / IG procedures and other applicable requirements, as well as providing inputs as required during audits, raising issues picked up with the HISDM

General/Other

To work closely with colleagues, study teams, service providers and external collaborators as required, providing support and input on database development, Information Governance and data security, or other relevant issues.
To work within a system of regular quality controls and at all times ensure compliance with Good Clinical Practice (GCP), the Data Protection Act, PCTU SOPs and information governance requirements, as well as other college policies and research regulations.
To train and keep up to date with PCTU & college policies and procedures and other regulatory requirements, as well as with the latest developments in the areas of database development, data protection, information governance and other systems used to support clinical research.
To play a key role contributing to the unit’s Information Governance (IG) and Information Security activities, including support for the ongoing implementation and yearly IG Toolkit assessment.
To research and advise the PCTU Head of Information Systems and Data Management on areas related to database development, information security and governance and server maintenance.
Prioritise own workload to ensure deadlines are met, using problem solving skills to identify and implement solutions; deciding on appropriate course of action; communicating effectively with colleagues; seeking guidance from other staff as required
To supervise the work of junior colleagues where required
Undertake such other reasonable duties as may be required by the line manager or Head of Information Systems and Data Management from time to time.
To carry out your responsibilities at all times with due regard to the College's Equal Opportunities and Health & Safety policies.

The above list of responsibilities is not exhaustive and the jobholder may be required to undertake other duties commensurate with the level of the role, as reasonable requested by their line manager.

This job description sets out the duties of the post at the time it was drawn up. Such duties may vary from time to time without changing the general character of the duties or level of the responsibility entailed. Such variations are a common occurrence and cannot in themselves justify a reconsideration of the grading of the post.

Job Profile
Job Description /

This table lists the essential and desirable requirements needed in order to perform the job effectively. Candidates will be shortlisted based on the extent to which they meet these requirements.

Requirements / Essential / Desirable
Qualifications / Educated to Degree level or above, or substantial relevant experience / E
Degree or postgraduate qualification in Computer Science or related field / D
Relevant IT certifications / D
Knowledge, / Authoritative knowledge of principles, theory, methodologies, and practice of database programming and Web development. / E
Skills and
Experience / Substantial experience in two or more of PHP, Java, and Python; including evidence of using at least one to significantly contribute to a large software development project. / E
Experience of database programming using SQL and database administration (for tools such as MySQL, PostgreSQL, Oracle or MS SQL Server). / E
In-depth experience of Web development using both client and server side technologies, including the development of Web services and source code management. / E
Experience of managing the full project life cycle for software development including evidence of business analysis and system specification skills. / E
Experience of administering Web servers and deploying Web applications on Windows and Linux Operating systems. / E
Advanced and recent working knowledge of Microsoft Excel and Access / E
Experience of writing system specifications and documenting technical work (for developers and end-users), and of training and supporting end-users / E
Experience with content management systems (CMS) such as Drupal or T4 / D
Experience with Electronic Data Capture (EDC) systems such as OpenClinica or RedCap / D
Good understanding of data protection regulation (Data Protection Act & GDPR) and information governance requirements for clinical research (IG Toolkit). / E
Knowledge of Regulatory framework for clinical trials (e.g. Good Clinical Practice, MHRA regulations, EU Clinical Trials Directive) / D
Excellent communication and interpersonal skills, with the ability to communicate effectively with colleagues and collaborators internally and externally / E
Excellent organisational skills, with the ability to prioritise your own workload effectively, work unsupervised or as an effective team member. / E
Proven analytical and problem solving skills / E
Effective project management skills for software development / E
Willingness to work flexibly, learn new skills and work in a changing environment / E

E – Essential: Requirements without which the job could not be done.

D – Desirable: Requirements that would enable the candidate to perform the job well.

Job Details
Job Title: / Senior Clinical Trials Applications Developer - System Administrator
School/Dept/Institute & Centre: / SMD •Blizard Institute •PCTU
Reports to: / Head of Information Systems and Data Management (HISDM)
Grade: / 5 PRO / Full Time
Appointment period: / 2 years
Current Location: / Whitechapel
Job Context
The Pragmatic Clinical Trials Unit (PCTU) situated within the Centre for Primary Care and Public Health and linked with the Centre for Psychiatry leads and supports clinical trials in which the primary question of interest relates to intervention effectiveness: whether an intervention works under real-life conditions. It also carries out and supports pilot studies for these trials. The unit focuses particularly on trials of complex interventions. In addition, staffs carry out methodological research relevant to the unit’s focus. The aim of the unit is to lead, support and encourage high quality pragmatic trials and pilot studies where they fit with the research strategies of the two centres with which the unit is linked, or with the methodological interests of the unit.
Job Purpose
This is a lead role for a multi-skilled senior Database/Web developer with systems administration and information governance/security skills.
Lead on all database/Web development, validation, documentation and support/maintenance activities for new and existing (mainly custom-built) applications using the latest Web development technologies available (Java, PHP and Python -based technologies are currently used).

Provide system administration support in liaison with Central IT to help maintain PCTU dedicated application servers and other systems supporting clinical research.
Act as key contributor to the unit’s Information Governance (IG) and data security activities, including support for the yearly IG Toolkit assessment and ongoing implementation.
Develop appropriate procedures, policies and documentation to support the main areas covered by the role.

Main Duties & Responsibilities

Leading System Administration and Server Maintenance

Provision of system administration (maintenance of PCTU database applications and systems such as MySQL/PostgreSQL/etc., maintenance of application servers such as Apache and other server-side software, deployment of Web applications, etc.) for dedicated servers hosting PCTU clinical research applications, in liaison with Central IT who host those servers. Most servers run on Windows or Linux operating systems.
Setting up and maintaining all off the shelf and custom-built applications on in liaison with Central IT (BCC and ITS)

Main Duties & Responsibilities

Liaison with Central IT on issues related to the administration of PCTU dedicated servers, Information Governance, data security and backup, setting up new servers, etc

Information Governance and Data Security

To be a key member and contribute to the unit’s Information Governance (IG) and Information Security activities, including support for the ongoing implementation and yearly IG Toolkit assessment.
Monitoring and ensuring that appropriate data security requirements are being met for all PCTU study datasets

General and Line Management

To work closely with colleagues, study teams, service providers and external collaborators as required, providing advice, support and input on database development, Information Governance and data security, system administration or other relevant issues.
To work within a system of regular quality controls and at all times ensure compliance with Good Clinical Practice (GCP), the Data Protection Act, PCTU SOPs and information governance requirements, as well as other college policies and research regulations.
To train and keep up to date with PCTU and college policies and procedures and other regulatory requirements, as well as with the latest developments in the areas of database development, data protection, information governance and other systems used to support clinical research.
To research and advise the PCTU Head of Information Systems and Data Management on areas related to database development, information security and governance and server maintenance.
Prioritise own workload to ensure deadlines are met, using problem solving skills to identify and implement solutions; deciding on appropriate course of action; communicating effectively with colleagues; seeking guidance from other staff as required
Line management and/or staff supervision responsibilities for junior colleagues as required, identifying training and development needs for the team
Undertake such other reasonable duties as may be required by the line manager or Head of Information Systems and Data Management from time to time.
To carry out your responsibilities at all times with due regard to the College's Equal Opportunities and Health and Safety policies.

The above list of responsibilities is not exhaustive and the jobholder may be required to undertake other duties commensurate with the level of the role, as reasonable requested by their line manager.

Job Profile
Person Specification /

This table lists the essential and desirable requirements needed in order to perform the job effectively. Candidates will be shortlisted based on the extent to which they meet these requirements.

Requirements / Essential / Desirable
Qualifications / Educated to Degree level or above, or substantial relevant experience / E
Degree or postgraduate qualification in Computer Science or related field with substantial database/Web development experience / E
Relevant IT certifications / D
Project Management certification (PRINCE 2) / D
Knowledge, / Substantial knowledge of principles, theory, methodologies, and practice of database programming
and Web development. / E
Skills and
Experience / Substantial experience in two or more of PHP, Java, and Python; including evidence of using at least one to significantly contribute to a large software development project. / E
Experience of database programming using SQL, PL/SQL and database administration (for tools such as MySQL, PostgreSQL, Oracle or MS SQL Server) / E
In-depth experience of Web development using both client and server side technologies, including the development of Web services and source code management. / E
Experience of managing the full project life cycle for software development including evidence of business analysis and system specification skills. / E
Experience of administering Web servers and deploying Web applications on Windows and Linux Operating systems / E
Experience of writing system specifications and documenting technical work (for developers and end-users), and training and supporting end-users / E
Experience with Electronic Data Capture (EDC) systems such as OpenClinica, RedCap, MACRO, etc. / D
Advanced IT skills and knowledge including programming skills in MS Office tools such as Excel and Access / E
Good understanding of data protection regulation (DPA 1998 & GDPR) and information governance and data security requirements for clinical research (IG Toolkit). / E
Knowledge of Regulatory framework for clinical trials (e.g. Good Clinical Practice, MHRA regulations, EU Clinical Trials Directive) / E
Excellent communication and interpersonal skills, with the ability to communicate effectively with colleagues and collaborators / E
Excellent organisational skills, with the ability to prioritise your own workload effectively, work unsupervised or as an effective team member. / E
Proven analytical and problem solving skills / E
Experience of line management and supervising the work of other colleagues / E
Effective project management skills particularly for software development / E
Willingness to work flexibly, learn new skills and work in a changing environment. / E

E – Essential: Requirements without which the job could not be done.

D – Desirable: Requirements that would enable the candidate to perform the job well.