Associate Director – Business Analysis (VEEVA)

Key Responsibilities:

• Lead and manage the gathering and documentation of business requirements specifically for the Veeva ClinOps Vault platform.
• Work closely with key business stakeholders and cross-functional teams to understand and document business processes related to clinical operations.
• Translate business needs into clear and actionable functional specifications for the development and configuration teams.
• Ensure that the business processes within the various ClinOps Vault modules (e.g., Study Start-Up, eTMF, CTMS) are fully understood, optimized, and aligned with platform capabilities.
• Develop a deep understanding of the business processes across different modules of the Veeva ClinOps Vault, including Study Start-Up, eTMF, CTMS, and more.
• Act as a subject matter expert for the ClinOps Vault platform, advising business users on best practices for utilizing the platform.
• Ensure that all business process changes, or new requirements are aligned with the overall platform strategy and capabilities.
• Serve as the liaison between business stakeholders, IT, and external vendors to ensure that business requirements are effectively captured, understood, and executed.
• Collaborate closely with platform architects, developers, and testers to ensure that solutions are designed and implemented to meet business requirements.
• Manage relationships with the business analyst vendor team, ensuring that vendor-delivered business analysis aligns with internal standards and objectives.
• Collaborate with the testing team to ensure that test plans, test cases, and validation processes align with the business requirements.
• Ensure compliance with GxP, regulatory requirements, and quality standards, particularly for validation testing.
• Ensure that all business requirements, processes, and related documentation are accurately captured and maintained.
• Provide regular updates and reports to senior leadership on the status of business analysis efforts, platform enhancements, and ongoing initiatives.

Key Qualifications:

Education:

• Bachelor's degree in Information Technology, Business Administration, or a related field. A Master’s degree or relevant certification (e.g., CBAP, PMP) is preferred.

Experience:

• 10-13 years of experience in business analysis, with at least 5-6 years of experience working in or around clinical operations, clinical systems, or related areas.
• Deep understanding of Veeva ClinOps Vault modules, including Study Start-Up, eTMF, CTMS, and their associated business processes.
• Proven experience managing business analysis for large-scale platforms in the pharma or life sciences industry.
• Demonstrated success in collaborating with stakeholders, translating business needs into technical requirements, and delivering solutions.
• Experience managing vendor teams and ensuring alignment with internal business objectives.

Skills:

• Strong business process understanding within clinical operations and the Veeva ClinOps Vault.
• Ability to translate complex business needs into clear, actionable requirements and specifications.
• Strong stakeholder management and communication skills, with the ability to collaborate effectively across various teams and levels of the organization.
• Solid understanding of test management, particularly as it relates to business requirement validation and regulatory compliance (e.g., GxP).
• Ability to manage multiple priorities, deliverables, and deadlines in a fast-paced environment.

Preferred Competencies:

• Familiarity with regulatory requirements such as GxP and clinical data management processes.
• Experience in managing business analysis and testing for validated systems in the pharma/biotech industry.
• Agile and Waterfall project management experience, with the ability to adapt as needed.

Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.