- Program/Project status reporting and tracking- Process design, requirements and technical specification development- Business Process Management

Delivered on time and within budget rollout of key upgrade to Electronic Data Collection (EDC) system for Early Stage and Late Stage Clinical development• Facilitated requirements elicitation sessions with keys Business Leaders/Subject Matter Experts and stewarded all SDLC documentation through all phases of project life cycle resulting in acceptance with minimum adaption costs • Ensured processes designed by business process reengineering teams aligned with technology changes being implemented• Identified, articulated and prioritized new product features and benefits and communicated to vendor

Enabled IT portfolio planning by developing multi-year business technology road-map and project cards for Early Stage and Late Stage Clinical development• Interviewed Business Area Leads/Subject Matter Experts to determine business drivers and pain points• Created SIPOCs, Business Interaction Diagrams, Capability matrices, current state and future state system diagrams and performed gap analysis • Facilitated identification and prioritization of projects based on findings and communicated out to stakholdersEnabled integrations between key Clinical Data Management systems after merger with Schering-Plough as Lead Reference Data Architect• Improved system data flows and avoided costly workarounds by analyzing business impact, proposing standardized format, and gaining consensus for key data items including protocol number, and subject identification number• Enabled business and IT understanding of post-merger complex system environment by creating legacy Merck and legacy Schering-Plough business process work-flows and IT system data flows for Clinical Development Management in one diagram • Informed technology and business reengineering efforts for new integrated ‘One Merck’ environment by creating and presenting interim and future state diagrams and system flows to various levels of business and IT Defined Mobility Strategy for Global Clinical Development group • Collaborated with GCD business leaders and IT colleagues to document opportunities, perform technical feasibility, gather business value, create scenarios/use cases and report out findings on mobile opportunities • Identified projects to be conducted as future experiments for Mobility Strategy

Delivered new EDC platform as part of major business reengineering effort enabled by the replacement of key components in the end to end Clinical Development technology environment leading to more efficient and improved clinical trial data management processes• Enabled vendor selection process by facilitating requirements elicitation sessions with keys Business Leaders/Subject Matter Experts and providing technical subject matter expertise during process• Ensured all IT activities were coordinated with vendor as IT lead for 9 early studies• Stewarded SDLC documentation throughout all phases of project life cycle resulting in acceptance for both internally and externally hosted environments with minimum adaption costs • Ensured processes designed by business process reengineering teams aligned with technology changes being implemented• Identified, articulated and prioritized new product features and benefits and presented to vendor and via Oracle User Group Meetings• Prepared for and responded to external regulatory inspection questions and internal audit findings and remediated internal systems based on those findings via Corrective Action and Preventative Action (CAPA) process

Successfully managed multiple projects and releases of evolving EDC systems in support of global clinical trials• Delivered on time within scope and budget TRIALink EDC System, including 9 early adoption studies and the interface with Merck's backend Clinical Trial System• Technical Team Lead for web based (Java) in-house developed EDC system (I-Trials), coordinating the work amongst the development team for multiple releases including SDLC documentation and validation• Technical owner and project manager for in-house development (Visual Basic and SQL plus) Remote Clinical Data Entry system, enabling data to be collected at clinical studies sites and transmitted to Merck's backend clinical data system• Lead developer of standard modules in Penergy/Presidio, defined requirements with clinical standards team, coordinated reviews of SDLC documentation, ensured proper verification testing • Managed vendor relationship ensuring key updates to Penergy/Presidio product were implemented and validated • Facilitated the selection process from various software vendors for a regulatory compliant statistical programming environment linking the SAS programs with the SAS datasets they were run against and the formatted tables/outputs the programs created and subsequently used in regulatory filings

Implemented Clinical Trial Electronic Data Collection applications using Penergy/Presidio platform (SmallTalk programming) allowing data to be collected in clinical trials to enable data entry on time and within budget in Early Stage and Late Stage Clinical development.

Implemented Call Center and Branch applications using Visual Age SmallTalk

Implemented middle-ware application (IBM DataTrade) as C programmer