eCOA Senior Project Analyst / Software Test Engineer
About the role
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We currently have an opportunity for a Senior Project Analyst/Software Test Engineer (STE)based on out of our Raleigh, North Carolina office but for the right candidate, home-based is acceptable. Senior Project Analyst/STE supports their assigned department or functional team through the independent management of assigned projects and tasks.
The Senior Project Analyst/STE works closely with other members of the project team, client, clinical/scientific teams, and internal and external clients and vendors for successful project execution. The Senior Project Analyst/STE may also support the training of more junior staff.
The Senior Project Analyst/STE is tasked with the development and testing of eCOA studies using a third party eCOA platform that has been integrated into ICON’s internal network/infrastructure. The SPA/STE is responsible for the testing of requirements for the configured study and for identifying any deviations from these requirements to the internal project team. They conduct the required testing activities to ensure all study requirements meet or exceed the sponsor’s expectations while ensure adherence to industry and software development standards. They participate in requirements review meetings and contribute feedback to the requirements for the configured study during these meetings. In addition, they work closely with the SPA/Configuration Analyst and eCOA PM to fully configure and develop the study through deployment, maintenance and closeout phases of the study. The SPA/STE is also responsible for the testing and delivery of translations/languages for their studies.
ICON PLC is a Clinical Research Organization with a strong global reputation in our approach to clinical development. We apply scientific and operational excellence across all phases of clinical trial outsourcing services for our clients. We have offices in 40 countries with over 80 offices worldwide and over 12K employees globally and an annual turnover in excess of $1.2 billion.
ICON’s Clinical Outcome Assessment (COA) services are geared to meet the demands of global and national markets for high quality patient-centered data. Our COA group brings together a large team of scientists and consultants with expertise in the selection, development, validation and analysis of Patient Reported Outcome (PRO) and other COA instruments. The group has a deep understanding of the marketplace and regulatory landscapes, and helps decision-makers to understand the value of patient endpoints and to estimate the impact of new health technologies.
ICON’s Electronic Clinical Outcome Assessment (eCOA) practice is a market leader in electronic observational measure development and validation. Our eCOA team combines opinion-leading scientific expertise and knowledge of marketplace and regulatory landscapes with consultancy skills and understanding of client needs.
If you are looking to join a company which will offer you a strong support network with an inspiring and motivating working environment, then this is the job for you.
Applicants must be able to demonstrate drive, passion and a strong sense of team working, along with a desire to progress within our organization. You will have at least 2 years of experience in Outcomes Research or eClinical/Clinical field or related services/industry. Successful candidates will also possess great communication skills and be comfortable managing a variety of tasks at one time. For the eCOA practice area:
- Strong understanding of the methods, practices, and technology being utilized in eCOA
- Organizes and monitors workloads of project team members and external resources to be in line with budget
- Responsible for managing projects while adhering to timelines, SOPs and performance metric standards
- Controls assigned project budgets, ensures timely issuance of purchase orders
- Supports the preparation of proposal documents with scientific leads, client management and project management staff.
- High proficiency in MS Word, PowerPoint and Excel.
- Training in GCP and other regulations and official Guidance to Industry affecting conduct of clinical trials and implementation of information systems supporting clinical trials, preferred
- Knowledgeable in the configuration, development and testing processes involved with mobile applications.
- Experience in working within an environment that follows a detailed SDLC.
- Works well with others to produce a final product that is efficient and streamlined for use by a naïve user as well as being free of errors.
- Functions well in a project team that consists of at least an eCOA PM, SPA/CA and SPA/STE.
- Familiarity with configuration tools within the eCOA industry used to development and support eCOA studies.
- Skilled in the implementation of languages in a clinical trial.
- Knowledgeable in industry standard testing processes and procedures.
In return, we offer a strong benefits package that includes comprehensive health and pension plans, competitive salary, holidays, and an incentive plan for strong performers. Additionally, we have cutting edge technology to ensure better outcomes.
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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