Establishes and maintains oversight of 3rd party IRT vendor
Works directly with study teams to gather requirements and ensure IRT system is developed in line with study protocol
Develops and manages system deployment timelines for IRT
Manages IRT documentation which include but is not limited to: requirements, user guides, training materials, and communication plans
Coordinates user acceptance testing
Manages the deployment of IRT applications with internal teams and contract vendor
Provides guidance related to contracted vendors’ functionality, performance, and processes
Works with Clinical Logistics and Biostats on the upload of key information (i.e., subject randomization and kit lists, etc.)
Oversees routine meetings with contract vendor regarding performance, issues identification/resolution, and risk management
Ensure effective training plans for IRT systems are developed for clinical teams and site personnel with the contract vendor
If required, attend Investigator Meetings or CRA Trainings to discuss system functionality and requirements
May require up to 25% travel

Requirements

Experience developing IRT systems for clinical trials
Working knowledge of the IRT terminology and computer programming terms
Through understanding clinical trial protocol and translated for system development
Knowledge of ICH/GCP and regulatory guidelines/directives; Disease/therapeutic area knowledge (a plus)
Understands current and future business trends and information
Leadership and negotiation skills; Mentoring/coaching skills
Ability to effectively multi-task and prioritize
Effective problem-solving skills
Written and verbal communication and presentation skills in small and large group settings
Project management and organizational skills
Computer skills, with competency in MS Office Suite
Cross functional and cross-cultural awareness
Ability to work in a matrix environment

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

IRT system developmentclinical trial protocoluser acceptance testingproject managementregulatory guidelinesclinical logisticsbiostatisticsproblem-solvingmulti-taskingorganizational skills

Soft Skills

leadershipnegotiationmentoringcoachingcommunicationpresentationcross-functional awarenesscross-cultural awarenessprioritizationeffective training