Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
The Sr. Manager, Interactive Response Technologies (IRT) is responsible for the management and oversight of all Medical Organization IRT related systems and capabilities. This position will establish and maintain strong working relationships with IRT service providers, as well as oversee all IRT system planning, setup, deployment, and maintenance activities, including but not limited to generation of system specifications, oversight of system builds, and assurance of adequate system testing/validation prior to go-live.
This position will manage IRT support of and integration with Clinical Operations and Clinical Supply vendor systems to ensure adequate, compliant, and transparent delivery of clinical supply to study sites in line with the clinical trial protocol and all applicable ICH GCP and regulatory requirements, and will also support development of system user roles to plan (including all applicable user roles and permissions required by clinical trial sites, Clinical Operations, Clinical Supply, Pharmacovigilance, and Clinical Development). This role will support system integration with sponsor reporting hubs as applicable (e.g., CTMS) and will ensure system reporting functionalities operate to plan (e.g., system generated reports, notifications, etc.). This position will support creation and maintenance of IRT related procedures and documentation (e.g. SOPs, Work Instructions, etc.), will oversee all IRT related updates and change controls, and will serve as the main POC for IRT related issue escalation and resolution. Candidates must have mastered clinical trial execution and must be able to oversee IRT functionality under ICH GCP requirements. Candidate must have the ability to prioritize multiple tasks, communicate effectively, and cultivate strong cross functional relationships.
What You'll Be Doing
- Act as SME/POC for all IRT related matters.
- Work cross-functionally to ensure accurate, timely, and compliant IRT system build and go-live.
- Ensure accuracy, feasibility, and completeness of IRT specifications.
- Ensure accurate and timely configuration of system capabilities and user roles/permissions, including all applicable user roles and permissions required by clinical trial sites, Clinical Operations, Clinical Supply, Pharmacovigilance, Clinical Development, etc.
- Ensure system masking/unmasking capabilities are setup, tested/validated, and function to plan.
- Ensure system configuration of randomization schedules are setup, tested/validated, and function to plan.
- Plan and facilitate IRT integration with all applicable Clinical Supply vendors/depots to ensure timely, accurate, and traceable delivery of clinical supplies to clinical trial sites.
- Plan and facilitate IRT integration with all applicable sponsor/vendor system as needed (e.g., CTMS, EDC, etc.).
- Ensure system reporting capabilities are in place, are fit for purpose, and function to plan (e.g., site/sponsor/CRO notifications, system generated reports, unmasking notifications, etc.).
- Work collaboratively with vendor, QA, and IT counterparts to ensure timely, adequate, and compliant system testing, validation, and go-live.
- Oversee IRT system enhancements, modifications, and change controls in alignment with business needs, best practices, and amendments to clinical trial plans/protocols.
- Create and manage system related standard operating procedures, plans, processes, etc.
- Serve as IRT POC for all issue escalation and resolution.
- Provide system training to users per Organization plans and procedures.
- Oversee user access requests.
- Establish and oversee IRT vendor contracts and budgets.
- Generate and manage IRT related purchase orders/change orders, process vendor invoices, and assist in budgeting as applicable.
- It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships, and using clear communication to meet shared objectives.
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
- Bachelor’s degree required with an emphasis on Life Sciences.
- At least 10 years clinical trial experience.
- At least 7 years IRT management experience.
- Must have working knowledge of ICH/GCP principals and demonstrate familiarity with industry standards.
- Ability to work in a dynamic, fast paced, team environment.
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. Apply for this job
