What You'll Do
- Review protocols and include required modules in the User Requirements Specification (URS)
- Perform highly skilled duties such as creating, reviewing, coordinating, and managing a variety of deliverables (including, but not limited to, timelines, KOM, URS, Communication Manual, Requirements for Subject Randomizations, and Clinical Trial Material Lists for assigned projects, User Acceptance Testing, and system set up)
- Ensure established timelines are met
- Facilitate and troubleshoot any issues associated with managing the delivery of RTMS systems
- Provide technical advice and assistance to other project managers, developers, validation, and customer support staff
- Responsible for Tier 3 on-call coverage (24/7/365)
- Acquire new knowledge and enhance your skills
Requirements
- Four-year degree or equivalent experience
- 2+ years of Project Management experience within the Clinical Trial Industry
- Ability to take the initiative and work proactively
- Superior organizational and communication skills
- Working Knowledge Microsoft Office
- Proven ability to work independently in a dynamic, fast-paced environment but also as part of a team
- A logical approach to problem-solving and an excellent eye for detail
- Excellent verbal and written communication, interpersonal, and presentation skills
- Ability to travel (~5-10%)
Nice to Have
- Working Knowledge of RTSM/IRT/IVRS/IWRS/IXRS
- Working Knowledge of FDA E6, E8, and 21 CFR Part 11
- Working Knowledge of Subject Randomizations and Clinical Trial Material lists
- Audit Preparedness
- Google Docs
