Job Description :
IKCON TECHNOLOGIES INC delivers exceptional IT services and solutions that provide clients with definite edge over competitors and promoting highest standards of quality. We are currently looking for a [IRT/IXR Technical Engineer/Lead] with one of our clients in [Madison], [NJ]. If you are actively looking for opportunities, please send us your updated resume with your contact details.







JOB TITLE


IRT/IXR TECHNICAL ENGINEER/LEAD




CITY


MADISON




STATE


NJ




TAX TERMS


W2




EXPERIENCE


8+ Years




INTERVIEW MODE


TELEPHONIC/ SKYPE







JOB DESCRIPTION

The IRT/IXR Technical Engineer/Lead will focus on implementing IRT/IXR software implementation for various studies using an agile approach to provide our clients fast, accurate solutions for a clinical trial. In depth knowledge or experience of clinical trials, specifications development, integrations, and data transfers are a must.



RESPONSBILITIES

Serve as onsite lead for client design consultations by:


Analyzing client requirements against system capabilities to determine implementation recommendations and best practices
Demonstrating a superior comprehension of internal IRT applications, guiding clients towards an optimal implementation both from a design complexity and from a site experience perspective
Providing technical expertise for the requirements process and working to continuously move internal and external specifications discussions in a forward and positive direction
Facilitating discussions between internal and external resources to ensure that the key stakeholders and SMEs are represented and that the design reflects expert opinion
Gathering, analyzing, refining, and finalizing managing Randomization Trial Supply Management (RTSM) user requirements from multiple sources in an iterative manner. Ensuring that a product/study will be delivered to the Customer in timely and accurate manner
Reviewing specification documents to ensure requirements are present and in the correct format
Developing the systems specifications including the User Requirements Specification (URS) from the study protocol, integrations with external systems, and other supporting applications such as reports
Coordinating the schedules of internal and external resources to ensure timely submission of requirements throughout the specification and design processes
Translating product features and functionality to the requirements definition stage to reduce confusion and conflict during the testing and "go live" phases of a study
Configuring study specific implementations within a robust web based UI for Bioclinica IRT based on study protocols and specifications
Conducting demonstrations of system implementations to clients during the development process
Soliciting client feedback during demonstrations and making adaptations to the configuration in real time when possible
Performing tasks associated with study configuration such as generation of kit lists, staging of data, and liaising with internal teams
Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)
Working closely with QA for clarification and documentation of deviations to SOPs



Assisting in establishing and enforcing departmental standards
Participating in the modification of company SOPs related to IRT Services
Attending and participating in applicable company sponsored training




MINIMUM QUALIFICATIONS


Bachelor s degree in life science or related field required
5+ years experience will be considered in lieu of a degree
2+ years experience in clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a business analysis or project management related role
IRT experience
Working knowledge of interactive response technologies, drug supply, randomization strategies