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Veeva

Posted 38 months ago

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Project Manager - RTSM

ZagrebRemoteFull-time

AI Summary

Project Manager for RTSM responsible for client liaison, leading meetings and trainings, and delivering user-friendly RTSM solutions in clinical trials.

About this role

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

Veeva Systems is looking for a Project Manager to join our Randomization & Trial Supply Management (RTSM) team. As a Project Manager, you will be the primary point of contact with the client, including leading client meetings and training sessions and highlighting the RTMS modules, which will deliver an effective, user-friendly RTSM system for end-users included in the study. Exceptional writing, editing/formatting, organization, and time management skills are a must.

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

    • Skills

    21 CFR Part 11Clinical Trial MaterialsClinical Trial ProcessesDocumentationFDA Part 11Google DocsGxPIRTIVRSIWRSIXRSKOMMicrosoft OfficePilot TestingProject ManagementQuality AssuranceRequirements GatheringRisk ManagementRTSMStakeholder ManagementTMFTrainingUATURSUser Acceptance TestingValidation

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