Digital Trial Consultant

Responsibilities:

• Support process improvement workstreams of trial sponsors or contract research organizations (CRO) for implementation of new Clinical Operations, Clinical Data or Digital Trial applications (e.g. Vault CTMS, EDC, eConsent, ePRO etc.).
• Lead the process or site engagement 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).
• Define and drive the customer’s business deployment plans, success criteria and site outreach program.
• Understand Vault Best Practices and design the customer’s future Vault business process
• Support the definition of system user requirements and contribute to system design workstreams (e.g. configuration, migration, integration, etc.).
• Assist with post-live analysis of reports and metrics to drive new process and user/site adoption and ensure established goals are met and improvements sustained
• As needed, serve as the primary customer liaison managing the project plan, communication, risks and project reporting between the Veeva and customer teams.
• Collaborate cross-functionally with Product, Strategy, Sales and Site Success/Support
• Ensure customer success from beginning to end of the engagement lifecycle.
• Work with an awesome team!

Requirements:

• Deep understanding of the different interactions between Sponsors, CROs, Sites and Subjects that happen during a clinical trial.
• 3+ years’ experience at a clinical research site or at a Sponsor / CRO working closely with Sites.
• 2+ years experience as a consultant, business analyst, or study lead
• Ability to build cross-functional relationships and “roll up your sleeves” to enable process and system implementations with speed
• Ability to travel as required
• Good communication skills in English
• Bachelor’s degree or equivalent required

Nice to Have:

• Proven track record contributing to process transformation and system implementations either as a consultant, business or IT representative for at least one of the following: eTMF, CTMS, SSU, EDC, eConsent, ePRO, or similar systems for managing clinical trials
• Experience authoring controlled documents (e.g. SOP) and training material
• Direct experience in a services organization or product company
• Experience with creating and managing project plans (e.g. Project Manager)
• Experience leading workshops / user interviews, developing procedural documents and conducting system training
• Experience defining and driving success criteria, performance metrics or study plans
• Experience in process management tools such as Microsoft Visio or Lucidchart
• Process or Change Management Certifications (Six Sigma, BPM, ITIL, PROSCI or equivalent)
• Knowledge in life sciences compliance and computer systems validation requirements
• Fluency in one or more of the following languages: German, French or Italian