Clinical, Safety & Development Platforms

CTMS & eClinical Program Leadership

Led multiple CTMS initiatives, including system assessments, replacements, and expansions, aligned to broader eClinical strategies.

• Phase 0 evaluations and roadmap development

• Addition of new CTMS platforms and modules

• Implementation of eFeasibility solutions to support investigator identification and PI screening

• Oversight of validation resources, QA partnership, and vendors operating without a defined PM

eTMF Implementation & Large-Scale Migrations

Program leadership for eTMF vendor selection, implementation, and operationalization.

• Conference-room POCs and SaaS implementation

• Development of TMF SOPs, work instructions, and operational checklists

• Migration of 3,000 to 1.5M+ documents from multiple CROs

• Hypercare oversight and inspection readiness support

Argus Safety Database Consolidation

Led migration and consolidation of multiple safety databases into a unified Argus environment.

• Vendor and CRO coordination

• Process harmonization across therapeutic programs

• Alignment with product launch timelines

• Improved visibility, control, and inspection readiness

Clinical Data & Trial Execution Support

Program leadership supporting trial execution and data readiness.

• Database lock planning and execution

• Clinical data review committee oversight

• Centralized data request and release processes

• Monitoring visit reporting and deviation tracking systems

Quality, Compliance & Inspection Readiness

Regulatory Inspection Readiness

Provided project leadership across inspection readiness threads.

• TMF storyboards, chronological narratives, and workflows

• Training development and collaboration room support

• Mock audit coordination

• Cross-functional support for Clinical and Pharmacovigilance teams

Computer System Validation (CSV) Oversight

Led validation efforts across regulated platforms.

• Direct partnership with QA

• Oversight of validation vendors and internal resources

• Validation planning, execution, and documentation review

• Support for audit and inspection responses

Quality & Document Management Platforms

Migration of non-validated repositories into compliant environments.

• Transition from custom document repositories to validated QMS platforms

• Role definition, governance, and access controls

• Alignment with regulatory expectations

Enterprise, R&D & Operational IT

SaaS & Cloud Migrations

Led enterprise and functional migrations from legacy environments to cloud-based platforms.

• Centralized data repositories with governance and security controls

• Cost optimization and business continuity improvements

• Enhanced collaboration and knowledge management

R&D Financial, Resource & Portfolio Systems

Program leadership for platforms supporting R&D planning and execution.

• Forecasting, budgeting, and payment tracking

• Global resource and demand management

• Agile delivery using backlog and sprint cycles

Collaboration & Knowledge Platforms

Delivery leadership for SharePoint and collaboration initiatives.

• Clinical and R&D reporting sites

• Pipeline and trial status dashboards

• Incremental enhancements via agile delivery

EH&S, Supply Chain & Compliance Programs

EH&S Regulatory Compliance Platforms

Program leadership for SaaS implementations supporting global compliance.

• Supplier and CMO regulatory data collection

• Integration with ERP systems (SAP / JDE)

• Global reporting and notification capabilities

Contractor Safety & Vetting Systems

Led implementation of SaaS platforms supporting contractor EH&S qualification.

• Internal and external data collection

• Coverage of high-risk operational contractors

• Standardized vetting and compliance processes

IT Governance, Security & Infrastructure

R&D Network Segmentation & Security

Program leadership focused on protecting R&D laboratory environments.

• Asset inventory and risk assessment

• Segmentation planning and execution

• Protection of research data integrity

CMDB Remediation & Governance

Led remediation and standardization of configuration management data.

• CI relationship correction

• Naming standards and role definition

• Ongoing governance processes

Salesforce & Platform Governance

Established governance models for enterprise platforms.

• Demand intake and prioritization

• SDLC and citizen development standards

• Executive review and approval structures