Veeva Clinical Architect

Responsibilities:

Solution Architecture Design: Lead the design and architecture of Veeva Vault solutions, ensuring alignment with business requirements and industry best practices. Develop and document high-level and detailed solution designs, including data models, workflows, integration patterns, and security frameworks.

Implementation Oversight: Oversee the implementation of Veeva Vault applications, ensuring adherence to architectural standards and project timelines. Provide technical leadership and guidance to development teams throughout the project lifecycle.

Integration Management: Design and manage integrations between Veeva Vault and other enterprise systems using APIs, middleware, and custom connectors. Ensure seamless data flow and synchronization across systems to support business processes.

Technical Strategy and Roadmap: Define and maintain the technical strategy and roadmap for Veeva Vault solutions, aligning with organizational goals and technological advancements. Evaluate new Veeva Vault features and releases, and plan for their adoption and implementation.

Solution Design and Configuration: Design, configure, and customize Veeva Vault applications, including 2 plus Vaults: Quality, Regulatory, and Clinical (eTMF & CTMS) to meet business requirements.

Compliance and Quality Assurance: Ensure all Veeva Vault solutions comply with relevant regulatory requirements (e.g., GxP, 21 CFR Part 11) and internal quality standards. Conduct technical reviews, validation, and testing to ensure the robustness and reliability of implemented solutions.

Stakeholder Collaboration: Collaborate with business stakeholders, project managers, and other architects to gather requirements, provide technical insights, and ensure alignment on project objectives. Present technical concepts and solutions to non-technical stakeholders in an understandable manner.

Technical Mentorship: Mentor and develop junior technical staff and provide technical training to the team as needed. Foster a culture of continuous learning and improvement within the technical team.

Education: Bachelor's degree in Computer Science, Information Technology, Bachelor's of Science Industrial Engineering or a related field.

Experience: Extensive experience (typically 7+ years) in IT with a strong focus on Veeva Vault solutions, including multiple successful project implementations.

Proven experience in designing and architecting complex Veeva Vault solutions in a regulated environment.

Technical Skills: Deep expertise in Veeva Vault configuration, customization, and integration.

Proficiency in relevant programming languages and tools such as Veeva Vault Java SDK, SQL, XML, and APIs.

Strong understanding of data modeling, database design, and data integration techniques.

Regulatory Knowledge: In-depth knowledge of regulatory requirements and guidelines (e.g., GxP, 21 CFR Part 11) relevant to the pharmaceutical and life sciences industries.

Leadership and Communication: Excellent leadership skills with the ability to lead technical teams and manage cross-functional collaboration. Strong communication and interpersonal skills to effectively interact with stakeholders at all levels.

Analytical and Problem-Solving Skills: Strong analytical and problem-solving abilities to address complex business requirements and technical challenges.Ability to think strategically and develop innovative solutions.

Lead comprehensive data migration initiatives for Veeva Vault, including detailed data mappings, meticulous planning, and seamless execution. Ensured accuracy and consistency of data throughout the migration process, adhering to regulatory and compliance standards. Collaborated with cross-functional teams to validate data integrity and perform rigorous testing to guarantee successful migration outcomes.

Certifications: Veeva Vault certification(s) mandatory. Additional certifications in enterprise architecture frameworks (e.g., TOGAF) or related areas are a plus.