Manager, Clinical Logistics & IRT ( IVRS / IWR)

Regeneron Pharmaceuticals
Oct 18, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.


Responsible for managing the activities related to Regeneron studies using an IRT (IVRS / IWR) system. Act as the primary contact for both internal and external (Contract Vendors & Partners) team members. Works directly with clinical trial management, data management, and clinical supply staff regarding system requirement specifications for deployment, and assists as needed for maintenance, and closeout activities. Assists with the development and management of IRT (IVRS / IWR) standards with contract vendors and manage internal expectations and communications around those standards. Ensures agreed upon timelines are maintained and communicate delivery challenges and risks. Coordinate all internal user acceptance testing requirements.


+ Work directly with all study teams in the gathering and development of requirements for all studies which require an IRT system.

+ Develop and manage system deployment timelines with contracted vendor.

+ Review and approve system documentation including user guides and training materials.

+ Coordinate internal user acceptance testing requirements.

+ Coordinate user acceptance testing (UAT) and deployment of IRT applications with internal teams and contract vendor.

+ Obtain and maintain a thorough understanding of contract vendor's functionality, performance, and processes.

+ Review IRT initial budgets and subsequent change orders with responsible internal teams

+ Work with Clinical Logistics teams on the upload of key information (i.e, kit list, batch numbers, expiry dates).

+ Establish and maintain routine meetings with contract vendor regarding performance, issues identification/resolution, and risk management.

+ Ensure effective training plans 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 also need to review IRT initial budgets and change orders with responsible internal stakeholders.

+ Bachelor's degree and at least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years working in an Integrated Response Technology (IRT) environment.

+ Experience developing IRT system plans and specifications.

+ Working knowledge of the IRT terminology and computer programming terms.

+ Through understanding of the clinical trial protocol development process.

+ 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.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. fec045c1b1c4bdf6fdf9cd3e