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Senior Consultant
Clinical Operations, Remote
Confirmed live in the last 24 hours
Locations
Raleigh, NC, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Oracle
Sales
Communications
Requirements
  • 8+ years of experience working with or for life sciences companies; including, Pharmaceutical, Biotechnology, Healthcare, and Medical Device, and Diagnostics organizations with knowledge of document and data control and storage
  • Direct system implementation experience either as a consultant, business, or IT representative for at least one of the following systems: Document Management (Documentum, OpenText, Sharepoint), CTMS, TMF, Study Startup, or eReg/ISF
  • Experience delivering or developing workshop material, training, gap analyses, or requirements gathering sessions with business and system stakeholders
  • Proven track record leading high-impact system implementations and the ability to collaborate and manage diverse stakeholders and ensure delivery to a high degree of satisfaction
  • Knowledgeable of life sciences compliance and computer systems validation requirements
  • Ability to act with speed to understand requirements, create corresponding solutions, and willingness to “roll up your sleeves” to design and implement a Clinical Operations solution
  • Ability to travel 50-75%
Responsibilities
  • Lead life science customers in the rapid configuration and implementation of eTMF, CTMS, Study Startup, and eReg/ISF solutions to support clinical trial data and content management needs at the world's largest pharmaceutical companies to emerging biotechs to Academic Research Centers
  • Manage software implementation projects and customers during the lifecycle of an implementation focusing on project planning, gap analyses, workshop delivery, requirements gathering, configuration, validation, migration, integration, training, and go-live activities
  • Guide our customers through successful implementations from inception through adoption, ensuring alignment of processes to system design and functionality. Think critically about business requirements to ensure the solution reflects business requirements and focuses on customer success and adoption
  • Serve as the primary customer liaison managing communication, risks, and project reporting between the project team, customer, and internal stakeholders
  • Mentor project team and consultants in the R&D Services organization and provide leadership for project teams
  • Collaborate cross-functionally with Product, Strategy, Sales, and other teams across the company
  • Ensure customer success from beginning to end of the engagement life cycle
Desired Qualifications
  • Direct experience with systems such as Oracle Siebel, goBalto, BioClinica CTMS, Medidata Rave CTMS/Strategic Monitoring, Parexel IMPACT, Bio-Optronics Clinical Conductor, PhlexEView, Trial Interactive, DrugDev Site Selection and Payments, WingSpan eTMF and SiteZONE, Complion, Florence eBinders, Forte Oncore and eReg, Veeva Vault, NextDocs, Documentum, SharePoint, other clinical technologies
  • Life science, computer science, or related degree
  • SaaS/Cloud experience including knowledge of systems validation
  • Experience in services delivery management and/or systems implementation
  • Master's degree
Veeva Systems

1,001-5,000 employees

Cloud computing services for pharmaceutical companies.
Company Overview
Veep's mission is to help R&D, quality, and regulatory teams eliminate inefficiencies and bring high-quality, safe, sustainable products to market without compromising quality. The company builds cloud-based tools for pharmaceutical research.
Benefits
  • Parental leave
  • PTO
  • Free food
  • Health, dental, & vision insurance
  • Gym membership reimbursement
Company Core Values
  • Do the Right Thing
  • Customer Success
  • Employee Success
  • Speed