Clinical Data Programming Lead
About the role
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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.
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.
We have an incredible opportunity for an expert Clinical Data Programming Lead to join the team.
The Role:
* Participates in study specific database set-up using Medidata Rave.
· Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
· Creates/Programs edit checks, special actions and derivations as per a DVS.
· Works closely with centralized CDMS Testing Group to ensure all programming issues are resolved in a timely manner and study timelines are met
· Trouble-shoots and solves study building issues and edit check programming issues.
· Set up Coder, IRT, T-SDV, and Rave Safety Gateway integrations.
· Run Screen Review Meetings with sponsors and act as point of contact for all Rave questions.
Serves as Team lead to CDMS Programmers, providing training, best practices, support and quality checks on study build and programming; ensure effective resource allocation and workload balancing across assigned team members
Extend technical expertise and mentor team members on an ongoing basis; ensure team achieves productivity and quality targets, perform benchmarking reviews and perform oversight of deliverables using different tools/ techniques and maintain and report relevant metrics. Contributes to training materials on a process, system or technology level. Works with CTD and CDMS. Management on delivery of training courses, instructor-led and on-the-job.
You will need:
* The successful individual will have a proven experience in study build set up; possess a strong understanding of the principles of system development lifecycle and governance and be able to perform assigned tasks with minimum supervision.
The requirements listed below are representative of the knowledge, skill, and/or ability required:
· Prior relevant experience in building study databases
· Ability to successfully manage multiple tasks and timelines
· Experience in Medidata Rave
· Team player with strong verbal and written communication skills
· Demonstrated ability to learn new technologies, applications and techniques
· Understanding of database concepts.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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