ICON Clinical Research

Sr Clinical Data Programmer

North Wales
04 Jun 2021
30 Jun 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The Senior Clinical Data Programming Lead role will be part of the ICON Medical Imaging Reporting & Analytics team responsible for clinical data specifications, SAS programming and delivery. To effectively assist the Director, Technical Management in leading the activities for those under his/her jurisdiction in a manner that ensures all timeframes and targets are met and that costs are kept under control.

The Senior Clinical Data Programming Lead is responsible for managing multiple clinical data delivery projects in accordance with established timelines, budget, quality standards and/or contractual requirements.
The Senior Clinical Data Programming Lead participates in activities as related to the specification, validation and quality assurance of study data deliverables and applies expert experience and knowledge in support of the clinical data programmers assigned to a clinical study.

* Creates and reviews deliverables such as Criteria Check Specifications and Report Requirement Specifications.
* Creates/Programs edit checks, special actions/functions, custom programs and derivations as per specification.
*Plans and schedules edit check test script writing, edit check programming and edit check validation. 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 reporting updates as specified per Change Request documents and procedures.
*Serves on project teams to coordinate and lead activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
*Trouble-shoots and solves study building issues and/or system integration issues, and/or change request issues using the appropriate applications.
* Creates advanced SAS custom programs as per specification, as required.
* May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data collection, to determine scope and limitations of the study and to discuss edit checks, derivations , testing and reports.
* Ensures high quality deliverables by providing senior review of study-level/program -level I multi­ study core deliveries for accuracy.
* Participates in special projects or tasks as directed by the Director, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress.
* Attends sponsor audits and assists with in-house audits, including the reporting process

* Maintain confidentiality of management information as appropriate.
* To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participate in Technical Management department initiatives.
* 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 Programmers and TPM group. 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 systems. Research and self-training is required to ensure that knowledge, particularly in relation to system functionality, is current.
* Ensures all queries to the 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.
* Contributes to training materials on a process, system or technology level. Works with ICON University and TM Management on delivery of training courses, instructor-led and on-the-job.
* Ensures programming processes are compliant with applicable SOPs.
* Respond to Business Development requests as required
* Administrative responsibilities include projecting the planning and tracking of projects, resource allocation, and supervision of programmers, medical terminologists, and/or forms designers.
* Participates in task assignment activities where required and acts as a back-up in Directors absence
* Ability to retrieve raw datasets.
* Other responsibilities may be assigned as required.

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.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

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.