Sr. Manager, Veeva Vault Systems Administration

Job Description Summary:

The Senior Manager, Veeva Vault System Administrator primary duty is to improve business processes with technology and provide local functional and process support. The candidate will provide functional and technical support, incident management, instance administration, release management, upgrade support, testing, as well as end user training to the business. Candidates must have a solid understanding of Veeva Vault, especially eTMF, Regulator, Quality, PromoMats and MedComms. These are power user types of roles, with some level of functional understanding of the implemented design, leveraging project and process support documentation and resources. Candidate must be self-directed, be a great team player, and have excellent communication skills to be considered for this role. This person works cross-functionally with internal departments and external resources on system and business process related issues. Preference given to those candidates who have experience in life sciences or FDA regulated industries.

The Senior Manager, Veeva Vault System Administrator ensures adherence to relevant regulatory requirements (e.g. 21 CFR Part 11 / EU Annex 11) and company Standard Operating Procedures (SOPs) as appropriate.
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Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Act as a Business Analyst, working with the business to understand business processes (clinical, regulatory, quality, medical and marketing) and requests for enabling appropriate solutions.

  • Extensive knowledge of document management systems

  • Extensive experience gathering & documenting business requirements

  • Solid understanding of Business Process Mapping, Business Requirements, Functional Requirements, Test Cases, User Guides and Admin Guides

  • Knowledge of Veeva Vault Platform

  • Familiarity with any of the following:

    • Quality business processes, such as electronic document management systems, document lifecycles, and / or change control, CAPA, Deviation, Audits/Inspections, Vendor Qualification business processes

    • Clinical business processes, such as electronic Trial Master File (eTMF) and / or clinical trial management systems (CTMS)

    • Regulatory business processes, such as regulatory document workflows, submissions, applications and / or registrations

    • Promotional and Medical materials

  • Support of end user Incidents

  • Configure enhancement requests in DEV, TEST and PRD environments and assist business users with troubleshooting and testing reported issues.

  • Liaise with Managed Service Provider or software vendor, as applicable

  • Provide relevant support for audit/inspection requests related to Veeva Vault systems.

  • Ad hoc data and document loads using Vault Loader and Vault File Manager as per business needs

  • Change Management processes; validation and Good Documentation Practices

  • Vault Reporting capabilities

  • Solid understanding of Vault security profiles and permission sets

  • Working knowledge of Vault Connectors and understanding of Vault-to-Vault transfers.

  • Veeva certifications desired

• Understand and support master data governance for business processes.

• Respond to requests for power user support and be available to address Tier 1 support (process support, master data, user access, user support and other non-technical issues)

• Maintain current knowledge base of solutions and work with Tier 2 and 3 support sustainment teams to facilitate technical break / fixes.

• Ability to prioritize and juggle multiple concurrent projects and day-to-day requests.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• A Bachelor's degree in Computer Science, Information Systems or other related field and a minimum of 5 years in a pharmaceutical, biotechnology or other regulated environment OR equivalent experience and/or education.

* Special knowledge or skills needed and/or licenses or certificates required.

• 5+ years of relevant Veeva Vault System Administrator experience, specifically with Clinical, Regulatory and / or Quality Vaults

• Advanced skill level with Microsoft Office, especially Excel, Word, PowerPoint, and Outlook

• Excellent verbal and written communication and training skills, and patience

• Ability to read, understand, and follow complex instructions

• People-oriented -- enjoys interacting with people and working on group projects