12 Month Fixed-Term Contract

The eCRF Designer/Developer will deliver high quality eCRFs (electronic case report forms) using Central Designer for healthcare related trials through design, development and unit testing. The post holder is responsible for developing solutions that are fit for purpose and compliant with regulatory requirements. The eCRF Designer/Developer is expected to use Oracle's Central Designer to author, design and develop eCRF and Edit Checks for InForm EDC systems based on user requirement specifications, following standards and methodologies.

The eCRF Designer/Developer is expected to be involved in trials at various stages of the development lifecycle.

Key Responsibilities Strategy and Planning:

- Involved in reviewing the provided requirements to assess the level of complexity needed from a development/ testing perspective

- Complete development activities based on assigned priorities, resolving conflicts where possible, otherwise escalate to Development team leader

- Assist the Development team leader with the management of the development life cycle as appropriate

- Participate in team meetings and provide regular progress updates Requirements & Solution Design:

Job Description

- Work as a member of the Clinical Trials development team to deliver trials that meet user requirements

- Work with the Validation / eCRF Test Analyst to ensure that requirements can be tested and clarify any inconsistencies or complexities with the design

- Work with the Production Support team to ensure that specific trial user account requirements can be implemented, highlighting any complexities or anomalies

- Work client-facing with trial teams as required to ensure that the trial design meets requirements using eCRF design best practice

- Translate user requirements into design specifications using Oracle's Central Designer - Design develop, and unit test InForm™ eCRFs and Edit Checks using Central Designer tool - Update associated MedML files as per requirements

- Update and maintain the Configuration Specification for individual trials - Implement changes to eCRFs and edit checks post UAT (User acceptance testing) and after trial golive as necessary.

- Implement the correct randomisation approach / details for the trial design as provided by the trial statistician/ trial team Solution Delivery:

- Interpret user requirements to develop eCRFs and combine with any library forms to produce an InForm trial - Deliver any specifications and user requirements as necessary ensuring they are filed and managed in a version-controlled environment

- Ensure all trial development documentation is maintained to a high level on an ongoing basis during development life cycle

- Generate deployment package for release of trials into the testing and production environment Analysis, Reporting and Documentation

- Review and implement any changes documented in the test logs, updating the documentation with solutions

- Keep track of development progress and provide regular updates on development progress in Development team meetings Quality Assurance:

- Ensure eCRF and Edit Check Specifications are developed to high quality by performing unit tests prior to releasing to System Testing

- Follow the defined development standards and methodologies

- Capture any assumptions, risk/issues as early as possible and escalate to Development Team Leader as appropriate - Assist with System Testing process and any validation / sanity checks when needed

- Creates or updates Standard Operating Procedures (SOP's) and Work Instructions (WI's) to allow knowledge transfer and improve process definition

- Attends and/or delivers training which ensures compliance with regulatory authorities and guidance by self or other team members

- Ensure specifications and required documentation is filed and managed in a version-controlled environment

- Actively participate in internal and external audits and inspections as defined by the audit plan; taking responsibility for responding to any CAPA / incident management related to eCRF design / development activities.

Solution Support:

- Provide support in the fixing of any issues or changes to eCRF and Edit Checks encountered during system testing, User Acceptance Testing (UAT) and deployment testing Job Description Continuous improvement:

- Maintain knowledge of development methods and new capabilities/ features adopted by the development team

- Provide advice and support to oth