Ora, Inc. · 6 hours ago
Interactive Response Technologies (IRT) Project Manager
United States
Full-time
Remote
Mid Level
3+ years exp
Maximize your interview chancesBiotechnologyConsulting
Insider Connection @Ora, Inc.
Get 3x more responses when you reach out via email instead of LinkedIn.
Responsibilities
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, including system enhancements and ongoing project evaluations for IRT.
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.
Serve as primary client contact for IRT.
Work with Clinical Data Managers and Statistical Leads with management of timelines and budgets as they pertain to IRT activities.
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.
Mentor IRT Programmer on IRT build requirements.
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.
Adherence to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
Responsibilities may differ from the above based on the specific needs of the business.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelor's degree in engineering, applied or life science, computer science or similar education required
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 that leads to timely and high-quality completion of the interdisciplinary team’s work
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
Expertise in clinical supply management, including the use of predictive algorithms for resupply forecasting
Strong Analytical Thinking
Proactive, Independent and Self-Motivated
Collaborative and Team-Oriented
Adaptable and Embraces Change
Skilled in Multitasking
Effective at Prioritization
Project Budget Expertise
Advanced Technological Skills
Benefits
Comprehensive healthcare options in Medical, Dental and Vision beginning day 1
Flexible PTO & Unlimited Sick Time
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
Company Paid Life & Disability Insurance
Remote & Wellness Reimbursement
Employee Assistance Program
Career Development Opportunities
Opportunities to work with colleagues across the globe
Company
Ora, Inc.
Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia.
201-500 employees
H1B Sponsorship
Ora, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Paul Colvin
Chief Operating Officer
Aron Shapiro
Sr. Vice President, Asset Development & Partnering
Recent News
Khaleej Times
2024-05-05
2024-02-19
2024-02-09
Company data provided by crunchbase
