Sr Clinical Data Programmer

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

CDMS:

* Serves as the lead on study specific database design within the CDMS system (i.e. Oracle RDC, Oracle Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical and CRF WorkManager), leading clinical database programming activities on multiple studies of complex design and expert in all areas for relevant CDMS.

* Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).

* Builds clinical study database CRF screens per CRF Specifications provided by project team.

* Creates/Programs edit checks, special actions/functions, custom programs and derivations as per a DVS.

*Plans and schedules edit check test script writing, edit check programming and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group. Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File.

*Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes

*Configures study specific data interfaces such as IVRS, labs, and CTMS.

*Trouble-shoots and solves study building issues and/or system integration issues (such as IVRS failures, CTMS issues), and/or change request issues using the appropriate applications.

* Creates advanced CDMS custom programs as per DVS, as required.

A Symbol of Excellence and procedures and presenting the validation documentation produced by the CDMS group.

* Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates, UAT dates)

* To act as a bridge between the Clinical Data Programmers and Validation Group within CDMS. Addressing technical clarifications and providing guidance as needed.

* Maintaining all necessary study documentation for the CRF build and edit checks.

* Keeps up-to-date with all software developments and release notes of assigned primary CDMS system. Research and self-training is required to ensure that CDMS knowledge, particularly in relation to system functionality, is current.

* Ensures all queries to the CDMS group are responded to in a timely manner, particularly when trouble-shooting an issue or answering a system functionality question. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved.

* Administrative responsibilities include projecting the planning and tracking of projects, resource allocation, and supervision of programmers, medical terminologists, and/or forms designers.

CDS:

*Serves as the clinical data delivery lead on multiple study specific programming setup, leading clinical data programming activities on multiple studies of complex design, with expert clinical data delivery experience and knowledge.

*Reviews specification documents created by study teams, such as data transformation specifications and programming specifications.

*Quality assures programming outputs and support validation activities per the formal, documented QC process.

*Plans and works with the clinical programming group to schedule specification, programming, validation and ongoing delivery activities. Manages timelines for programming setup process, ensures issues are addressed in a timely manner to meet timelines and produces clinical data delivery validation packages for delivery to the study teams to file in the Trial Master File.

*Co-ordinates and manages study database updates and out of scope impacts as specified per Change Request documents and procedures.

Benefits of Working in ICON:

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.