Interactive Response Technologies Project Manager

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Ora

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Allergy • Dry Eye • Retina • Anti-Infective • Anti-Inflammatory

201 - 500

Description

• Oversees and coordinates all IRT activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout. • Manages the day-to-day IRT project activities including, but not limited to, timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). • Mentors/trains IRT Programmer on IRT build requirements. • Lead the setup of IRT studies, including designing IRT systems, creating specification documents (with edit checks), obtaining approvals, and conducting user acceptance testing. • Serve as the primary point of contact for all randomization and trial supply-related issues during study conduct. • Ensure IRT systems align with the study protocol and meet all system requirements. • Provide guidance and insight on IRT best practices and emerging trends to cross-functional teams. • Allocate and prioritize workloads for multiple projects. • Manage unmasking data while safeguarding the integrity of the mask. • Work with study team to reconcile IRT data with clinical data and oversees data transfers. • Develop documentation for validation and maintenance of IRT databases for clinical trials using a variety of validated software applications. • Maintain quality control of the data, project deliverables and closeouts. • Maintain SOPs and tools relating to the IRT. • Adhere to all aspects of Ora’s quality system.

Requirements

• Bachelor's degree in engineering, applied or life science, computer science or similar education required and at least three (3) years of experience in project management of an IRT system. • Exceptional working knowledge of clinical trials and IRT role in the clinical trials process. • Effective leadership: skilled in analytical evaluation, organization, delegation, flexible team and project management, communication, negotiation and resource management. • Training and experience in clinical database management. • General knowledge of GCPs and the conduct of clinical trials. • Understanding of the clinical research process flow and drug development processes. • Understanding of software development and testing processes. • Proficient in Microsoft Office applications, IRT systems and EDC. • Ability to learn new systems without formal training. • Proven experience with the Software Development Life Cycle (SDLC) and collaborating within cross-functional teams. • Hands-on experience with various randomization schemes and methodologies.

Benefits

• Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1. • Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. • Competitive salaries along with a 401K plan through Fidelity with company match. • Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. • Offering peace of mind to help you and your family feel secure. • We'll reimburse you to support your remote workspace and wellness purchases. • No matter what issues you're facing, New Directions is here to help you and your family. • Continued opportunities to grow and develop your career journey. • Opportunities to work with colleagues across the globe. • A chance to research new ophthalmic therapies that will impact patients across the globe.