Project 1: Enterprise PMO Uplift for Biopharmaceutical R&D
Led PMO maturity assessment and governance uplift for clinical and R&D IT initiatives, standardizing project intake, portfolio oversight, and executive decision-making.

Problem:
The client lacked standardized governance and project intake processes for clinical operations and R&D IT initiatives, causing delays and misaligned priorities.

Action:

Led PMO maturity assessment and governance uplift. Standardized project intake, portfolio oversight, and executive decision-making. Established dashboards and reporting for executive stakeholders

Result:
Improved transparency, reduced project delays by 20%, and enhanced executive decision-making.

Project 2: SaaS-Based eTMF Implementation
Led SaaS eTMF vendor selection, configuration, and validation to streamline clinical trial documentation and ensure regulatory compliance.

Problem:
Manual and disparate trial master file systems slowed clinical operations.

Action:
Managed vendor selection, system configuration, validation, and deployment across Phase III trials. Developed SOPs, coordinated cross-functional teams, and ensured GxP-compliant inspection readiness.

Result:
Deployed eTMF across Phase III trials, reducing document retrieval time by 40% and achieving full regulatory compliance.

Project 3: Oracle to Veeva Supply Chain Data Migration
Directed the migration of legacy supply chain data from Oracle to Veeva, ensuring validated operations and data integrity.

Problem:
Legacy Oracle supply chain systems needed migration to Veeva to support validated operations.

Action:
Executed data mapping, migration strategy, and validation. Coordinated internal and vendor teams and developed dashboards to track progress.

Result:
Completed migration with zero critical errors, ensuring regulatory compliance and streamlined operations.

Project 4: Clinical Data Portal Development
Program-managed the design and deployment of a clinical data portal integrating multiple sources to enhance collaboration across R&D teams.

Problem:
Clinical teams lacked consolidated access to therapeutic area data, slowing collaboration.

Action:
Integrated multiple data sources, ensured compliance with security and regulatory standards, and deployed the portal for multi-site collaboration.

Result:
Reduced data access time by 50% and enabled collaborative decision-making across global R&D programs.

Project 5: Enterprise Disaster Recovery Implementation
Directed enterprise-wide disaster recovery strategy, implementing redundant systems and validating operational readiness.

Problem:
Inconsistent disaster recovery capabilities put critical operations at risk.

Action:
Implemented redundant systems, conducted validation testing, and trained operational teams. Aligned policies with SOX and industry standards.

Result:
Achieved validated enterprise-wide DR readiness, reducing potential downtime from days to hours.

Project 6: GxP-Compliant IT Governance & Inspection Readiness
Strengthened IT governance to support GxP systems and regulatory inspections, improving audit readiness.

Problem:
The organization required strengthened IT governance to support GxP systems, regulatory inspections, and ongoing audit readiness.

Action:
Developed and enforced GxP-compliant IT SOPs, managed validation oversight, change control, and CAPA support in partnership with Quality, IT, and business leadership.

Result:
Achieved sustained inspection readiness with no critical IT findings and improved audit confidence across regulated systems.

Project 7: Clinical Trial Management System (CTMS) Replacement
Managed replacement of a legacy CTMS platform, improving clinical trial visibility, reporting, and operational efficiency.

Problem:
The legacy CTMS platform could not support evolving clinical operations and reporting requirements.

Action:
Oversaw requirements definition, vendor coordination, system integration, testing, and validation across clinical operations, data management, and IT stakeholders.

Result:
Delivered a modernized CTMS solution, improving trial visibility, reporting accuracy, and operational efficiency across global studies.

Project 8: Clinical Safety & Argus Data Migration
Led migration of safety data into a validated Argus environment, ensuring compliance and uninterrupted pharmacovigilance operations.

Problem:
The organization needed to migrate safety data into a validated Argus environment without disrupting ongoing operations.

Action:
Planned and executed data migration and validation, coordinating vendors, internal IT, and safety teams.

Result:
Completed validated migration with zero critical data issues, enabling compliant and uninterrupted safety reporting.

Project 9: Vendor Selection & FSP Onboarding for Clinical Programs
Directed vendor selection and onboarding of Functional Service Providers (FSPs) to support multiple Phase III clinical programs.

Problem:
Rapid expansion of clinical programs required onboarding FSPs while maintaining delivery quality and governance.

Action:
Coordinated vendor selection, contract management, onboarding governance, and integration into clinical and IT operating models. Established performance metrics and reporting structures.

Result:
Successfully onboarded FSPs supporting multiple Phase III programs while maintaining delivery timelines and quality standards.

Project 10: Business Continuity & Disaster Recovery Program Establishment
Established a validated BC/DR framework for critical life sciences IT systems, reducing operational risk.

Problem:
The organization lacked a formal, tested Business Continuity and Disaster Recovery (BC/DR) framework.

Action:
Designed and implemented BC/DR strategy, recovery procedures, and validation testing with cross-functional participation, aligned with regulatory expectations.

Result:
Established validated BC/DR capability, significantly reducing operational risk and improving enterprise resilience.

For a full view of my IT and life sciences program leadership experience, please visit my LinkedIn profile

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