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Senior Consultant
Clinical Process Development, Remote
Confirmed live in the last 24 hours
Locations
Raleigh, NC, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Leadership
Management
R
Oracle
Research
Sales
Requirements
  • 10+ years of experience in clinical operations, site monitoring, study startup, TMF operations, and/or trial management
  • Direct system implementation experience either as a consultant, business, or IT representative for at least one of the following: eTMF, CTMS, Study Startup, Payments, or similar systems for managing clinical trials
  • Proven track record leading process transformation programs, including influencing business leaders
  • Experience leading workshops/user interviews, developing procedural documents and conducting system training
  • Experience in process management tools such as Microsoft Visio or Lucidchart
  • Ability to build cross-functional relationships and “roll up your sleeves” to enable process and system implementations with speed
  • Ability to travel 25-50%
  • Bachelor's degree or equivalent required
Responsibilities
  • Plan and lead process improvement workstreams of trial sponsors or contract research organizations (CRO) to support customers' implementation of new clinical operations applications (e.g. Vault eTMF, CTMS, SSU, Payments, etc.)
  • Lead the process redesign with customer stakeholders and SMEs. Understand their current state and future goals. Develop and facilitate the review and approval of new process flows and associated procedural documents (e.g. SOP)
  • Understand and define Vault Best Practices. Identify opportunities for customers to leverage Veeva products for their process optimizations
  • Support the definition of system user requirements and contribute to, or lead, system design workstreams (e.g. configuration, migration, integration, etc.)
  • Define the customer's business deployment plans, key performance indicators, and post-live governance
  • As needed, serve as the primary customer liaison managing the project plan, communication, risks, and project reporting between the Veeva and customer teams
  • Assist with post-live analysis of reports and metrics to drive new process and system adoption and ensure established goals are met and improvements sustained
  • Mentor project team and consultants in the R&D Services organization and provide leadership for project teams
  • Collaborate cross-functionally with Product, Strategy, Sales
  • Ensure customer success from beginning to end of the engagement lifecycle
Desired Qualifications
  • Applicable work experience as a consultant, business analyst, or solution architect
  • Direct experience in a services organization or product company
  • Experienced project manager
  • 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
  • Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)
  • Process or Change Management Certifications (Six Sigma, BPM, ITIL, PROSCI or equivalent)
  • Knowledge in life sciences compliance and computer systems validation requirements
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 Values
  • Do the Right Thing
  • Customer Success
  • Employee Success
  • Speed