Sr Clinical Data Programmer

Senior Clinical Data Programmer (SCDP) at Novotech

As part of Novotech s Clinical Data Programming unit, the Senior Clinical Data Programmer (SCDP) is responsible for database and application development work across multiple clinical data management projects, ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. The SCDP acts as primary point of contact for project team members to address and resolve issues at technical and DB development level.

Responsibilities:

1. Participate in Client and Project meetings as required to explain the CDP requirements, process and through-put times.
2. Undertake trouble shooting and resolution of any technical issues. Liaise with data management, statistical and clinical teams to ensure efficient operations and problem resolution. Liaise with internal Biometrics specialised teams to resolve issues affecting timely completion of CDP deliverables. Escalate issues to Manager CDP and Director CDP, as required.
3. Undertake advanced programming/custom functions for study DB edit checks and configuration and development of other system requirements.
4. Undertake quality and technical reviews of team members critical CDP deliverables as part of database builds, database migrations, database lock and database decommissioning activities, as well as CDP filing of critical documentation required in the TMF.
5. Undertake technical scoping and impact analysis for system changes and migrations.
6. Review validation results and undertake development fixes. Proactively identify and communicate risk and database update requirements.
7. Undertake and oversee deployments.
8. Evaluate technologies and applications for departmental use. Review system release notes and maintain up-to-date knowledge of applications.
9. Author ad-hoc functional requirements documentation.
10. Undertake troubleshooting of software issues in projects with EDC vendors via the EDC Vendor s Help Desk. Escalate business critical issues requiring immediate resolution to Manager, CDP, for further escalation within the EDC vendor.
11. Provide training and mentoring to new and existing CDP team members in SOPs, software applications, and programming best practices including use of standardized CRFs, edit checks, programs from the available generic and disease specific libraries.
12. Take an active role in the development of best practices, process improvement, quality control and governance related to all data programming activities.

Minimum Qualifications Experience:

Graduate in information science or life science related field, or similar. More than five years experience in a Senior Clinical Data Programmer role in a pharmaceutical company, CRO or EDC software provider, including supervision and training of other programmers. Familiar with programming languages including Java and C#.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

Minimum Qualifications Experience:

Graduate in information science or life science related field, or similar. More than five years experience in a Senior Clinical Data Programmer role in a pharmaceutical company, CRO or EDC software provider, including supervision and training of other programmers. Familiar with programming languages including Java and C#.

Responsibilities:

1. Participate in Client and Project meetings as required to explain the CDP requirements, process and through-put times.
2. Undertake trouble shooting and resolution of any technical issues. Liaise with data management, statistical and clinical teams to ensure efficient operations and problem resolution. Liaise with internal Biometrics specialised teams to resolve issues affecting timely completion of CDP deliverables. Escalate issues to Manager CDP and Director CDP, as required.
3. Undertake advanced programming/custom functions for study DB edit checks and configuration and development of other system requirements.
4. Undertake quality and technical reviews of team members critical CDP deliverables as part of database builds, database migrations, database lock and database decommissioning activities, as well as CDP filing of critical documentation required in the TMF.
5. Undertake technical scoping and impact analysis for system changes and migrations.
6. Review validation results and undertake development fixes. Proactively identify and communicate risk and database update requirements.
7. Undertake and oversee deployments.
8. Evaluate technologies and applications for departmental use. Review system release notes and maintain up-to-date knowledge of applications.
9. Author ad-hoc functional requirements documentation.
10. Undertake troubleshooting of software issues in projects with EDC vendors via the EDC Vendor s Help Desk. Escalate business critical issues requiring immediate resolution to Manager, CDP, for further escalation within the EDC vendor.
11. Provide training and mentoring to new and existing CDP team members in SOPs, software applications, and programming best practices including use of standardized CRFs, edit checks, programs from the available generic and disease specific libraries.
12. Take an active role in the development of best practices, process improvement, quality control and governance related to all data programming activities.

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