Interactive Response Technologies (IRT) Project Manager - Ora

POSITION TITLE: Interactive Response Technologies Project Manager 

DEPARTMENT: Interactive Response Technologies (IRT)

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia and Latin America.

The Role:

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. 

What You'll Do:

• 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.

What We Look For:

• Experience needed for the Role: 
• • 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

• Additional Skills and Attributes:
  • 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

Competencies and Personal Traits:

• • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience and empathy. Scientific, intellectual and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:

• Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.  
• Financial: Competitive salaries along with a 401K plan through Fidelity with company match. 
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. 
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. 
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. 
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. 
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.  
• Global Team: Opportunities to work with colleagues across the globe. 
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. 

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. 

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. 

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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