Sunovion Pharmaceuticals is looking for a Sr. Manager, Interactive Response Technology (IRT), User Acceptance Testing (UAT)to join our Clinical Trial Materials Management team in Marlborough, MA.
The IRT UAT Sr. Manager uses technical, industry and interpersonal skills to develop and oversee the execution of User Acceptance Testing (UAT) Plans for Interactive Response Technology (IRT) customized for clinical study. This includes but is not limited to performing quality reviews of the User Requirements Specification and Study Protocol, creation of Test Scripts, responsible for User Acceptance Testing deliverables, following the UAT process and training testers and other Sunovion & external vendor staff in UAT execution. The Sr. Manager contributes to the IRT interfaces with Clinical Trial Management System (CTMS) and Clinical Inventory Management System (CIMS), and the clinical supply technology infrastructure.
Ability to function as Subject Matter Expert of IRT UAT, responsible for UAT standards and support all new IRT UAT and updates.
Understand how to test the components of at least one IRT System from a recognized vendor.
Contribute to the UAT of IRT by:
* Assess vendor qualification of IRT System.
* Creation and maintenance of UAT Plans and Test Scripts.
* Providing appropriate notifications and feedback on the results of testing.
* Actively participating in internal meetings.
* Providing constructive feedback to peers, project team leads and managers, and functional management.
* Creation and maintenance of Acceptance Testing documentation.
Fulfill all administrative requirements of the position including:
* Develop & Maintain IRT UAT standards (SOP and Template).
* Develop a strong understanding of industry-related practices.
Collaborate with both Sponsor external vendors and internal functions to develop scenarios for testing purposes.
Participate in or lead Sunovion initiatives as directed by functional management.
Contribute to generation, refinement and maintenance of CTMM technology infrastructure.
* IRT standardization and process.
* Interface with, and enhancement of, Clinical Inventory Management System and Clinical Trial Management System.
* Value added novel CTMM technology identification and assessment.
* Comply with ICH, Federal U.S. and any pertinent local regulations and adhere to Sunovion policy, SOP and Guidance Documents.
Minimum Education, Experience, Knowledge and Skills Required:
* Bachelor's degree in Computer Sciences. Engineering or Science fields, or Business.
* Biopharmaceutical and drug development skill/experience in drug supply and global clinical development/operation areas.
* Team work and team leadership skills.
* Strong technical and Interactive Responsive Technology background, and familiar with two or more IRT systems, with 7+ year experience hands-on configuration experience and customization IRT and Clinical Study Protocol.
* Familiar with clinical study strategy, tactic approaches and execution reality.
* Most familiar with system build and functionality.
* Speaks the same language as IRT Vendor (various).
* Equipped with validation experience.
* Expert at determining what and how much to test Strong Project Management skills.
* Excellent people & communication skills (written and verbal).
* Excellent Presentation Skills.
* Ability to train in person and remotely.
* Excellent organization skills.
* Quick Learner.
* Demonstrated problem-solving skills.
* Working experience with Oracle IRT and Bracket PMD is preferred.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.