eSource Study Designer

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.

eSource Study Designer- ClinSpark- San Antonio ,TX – Hybrid  - Remote considerations for qualified candidates

The Electronic Systems Associated (ESA) will coordinate and manage the study design build and review process using the electronic system.

•  The ESA will work with the study Principal Investigator (PI) and Sub Investigators (Sub-I), Study Manager (SM) and Clinical Supervisors for project scheduling, and study design, and requirements. 

•   ESA will also work with Scientific Services and Data Management when applicable to ensure the electronic system study build will meet their requirements for final Clinical Study Report.

•  ESA will be a main point of contact between the Electronic System Lead/Core Team and the site/department representatives for End User Training assistance and personnel and technical support related to the system.  This role will also be responsible for assisting with ongoing training and support needs of their local sites.

•  Ability to understand protocol requirements and communicate those requirements to the clinical project team and apply that knowledge within the electronic system study design.

•  Ability to evaluate protocol procedures within the study design to ensure accuracy and validity of the study build within the electronic system. 

•  Obtain input of the project team (clinical, lab, pharmacy, etc.) as it pertains to the development of the study build within electronic systems.

• Coordinate with Electronic Systems Lead/SM to ensure appropriate timelines are being met to ensure that study build is within our contractual obligations.

•  Attend meetings with Sponsors for assigned protocol, as required.

•  Participate in meetings to include Sponsor start-up meetings, clinical tracking, mock runs and Monitor visits as required.

• Main point of contact for Electronic Systems Lead during system application upgrades.

•  Lead in onsite activities related to electronic systems such as End User Training and execution of Pilot Studies.

• Lead in Sponsor/Monitor training to provide the client with the knowledge to work within the electronic system for monitoring and review of data and query generation.

• Provides assistance in testing and validation of system releases as needed

• Assist in the implementation of electronic systems across all sites where applicable.

• Carry out clinical study directives from the Medical Directors, Assoc. Medical Directors, Sub Investigators and Senior Management Team.

• Undertake other reasonably related duties as may be assigned from time to time.• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

• As a member of staff, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

•  Travel (approximately 10%) domestic and/or international.

• Familiarize, understand and apply all SOPs applicable to job description.

Looking for Skills/Experience In:
• Must be experienced with eSource/EDC design (ClinSpark experience is a plus)
• Strong and effective communication skills
• Ability to multi-task with strong planning and organizational skills
• Ability to adapt quickly to a fast-paced and constantly changing environment
• Attention to detail
• Self-motivated with ability to work independently
• Strong problem solving and constructing thinking skills
• Knowledge and understanding of regulatory guidelines/requirements related to electronic systems in clinical research

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.