Project Manager - RTSM

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. They are seeking a Project Manager to join their Randomization & Trial Supply Management (RTSM) team, where the primary responsibilities include leading client interactions and managing deliverables to ensure effective system delivery for clinical trials.

Responsibilities:

• 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 (included, 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 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
• Must have RTSM experience
• 2+ years of Project Management experience within the Clinical Trial Industry
• Ability to take initiative and work proactively
• Superior organizational and communication skills
• Working Knowledge Microsoft Office
• Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team
• A logical approach to problem-solving and excellent eye for detail
• Excellent verbal and written communication, interpersonal, and presentation skills
• Ability to travel (5-10%)
• Working Knowledge of RTSM/IRT/IVRS/IWRS/IXRS
• Working Knowledge of FDA E6, E8, and 21 CFR Part 11
• Working Knowledge Subject Randomizations and Clinical Trial Material lists
• Audit Preparedness
• Google Docs