Serves as lead design consultant on multiple studies or programs of all complexities and size scales,potentially across multiple trial platforms. Partners directly with project team leaders and clientrepresentatives to conduct design review meetings and oversees the development and maintenanceof project timelines, ensuring forecasting of resources is maintained. Ensures study budgets are metand adherence to working practice documents and SOPS by maintaining knowledge of relevantcontractual obligations or limits with clients. • Interprets study protocol for design. Reviews designs for compliance/feasibility within thedatabase system and consistency with current standards and/or sponsor specifications. • Leads development of optimal design reducing the number of edit checks required, ensuring goodsystem performance, development and utilization of global/client specific libraries to ensureconsistency and efficiency. Escalates potential quality issues to management.• Plans and conducts internal and sponsor team meetings for determining data collectionrequirements and for review of study designs. • Designs and updates data collection forms based on study protocol requirements, corporatestandards, best practices, and feedback from internal and sponsor study teams. • Provides training and support to junior team members to ensure they have necessary skills tomeet their deliverable.• Leads/participates in drafting essential documents (i.e. Reports programming Specifications, DataImport Agreements, etc.). • Communicates any project risks to management, including potentially missed timelines andworking outside of the original budget or scope-of-work expectations. • Leads Global Process improvement initiatives, including Sponsor/internal design libraries asnecessary. Supports and develops standards ensuring alignment with other functional groupsassociated.• May contribute to department recruitment/candidate interview process.

Fulfilled the need to analyze, define and document the technical design requirements for datacollection methods within the Clinical Data Management System on studies of significant complexity. • Interpreted the study protocol for design in EDC. Reviewed designs for compliance/feasibilitywithin the database system and consistency with any current standards and/or sponsorspecifications. • Led development of Clinical Study Design and Specification documentation to support efficientDatabase Build/UAT. Optimized the design reducing the number of edit checks required to ensuregood system performance. • Met with study teams on a regular basis during initial study setup to ensure effectivecommunication and accuracy in design. • Led/participated in development of complex Database Modification Request Specifications. • Consulted with managers and programmers during the startup process on design/specificationquestions. • Provided training and mentoring to junior team members. • Reviewed and maintained training documents relevant to database design activities. • Updated tracking system to ensure resourcing projections were accurate for the team. • Contributed to the development of departmental WPDs and SOPs. • Communicated any project risks to the Study manager (i.e. potential missed timeline, workingoutside of budget or scope-of-work expectations, etc.). • Escalated potential quality issues to management. • Managed multiple study design projects at the same time and may have worked across multipletrial platforms. • Identified areas for process improvement and actively participated in process improvementinitiatives. • Utilized global/client specific libraries to ensure consistency and efficiency. • Contributed to the development of departmental WPDs and SOPs. • May have provided additional support to the department (i.e. representing the company atindustry conferences, presenting/teaching at department meetings, etc.).

Fulfilled the need to analyze, define and document the technical design requirements for datacollection methods within the Clinical Data Management System. • Led development of Clinical Study Design and Specification documentation to support efficientDatabase Build/UAT.• Led/Participated in development of medium to complex Database Modification RequestSpecifications, as determined by the DM Global Teams. • Consulted with managers and programmers during Clinical Database Start-Up Process ondesign/Specification questions.• Understood and followed departmental and corporate WPDs and SOPs, and contributed to theirdevelopment as needed.• Interpreted the study protocol for design in EDC.• Reviewed build timelines and provided inputs.• Utilized global/client specific libraries to ensure consistency and efficiency.• Understood and supported the implementation and design requirements of new tools andtechnologies for the EDC.

Provided technical leadership.Designed and implemented global library and study specific setup for clinical trials applications.Developed and validated data validation procedures.Provided first-line end-user support and problem solving.Provided leadership for application validation activities.Participated in the design and implementation of tools and techniques associated with increasingbusiness efficiencies.Provided support for end-user training.OC and RDC Specialist involved with providing input to the Database Design and Build Process team, which set standards on processes, researched issues and upgrades, and provided support to individual studies.Participated in various Oracle Health Sciences User Group focus groups

Performed Lead CDA role for assigned projects.Served on the PPD Project Team.Responsible for key CDM project deliverables.Developed and performed checks on the clinical data in accordance with the study specific guidelines to ensure its validity.Performed quality control activities.Ensured all necessary project documentation is created and filed correctly.

Assisted Lead CDA with project setup and execution.Performed Lead CDA role for select projects.Performed checks on the clinical data in accordance with the study specific guidelines to ensure itsvalidity.Performed quality control activities and ensures all necessary documentation is created and filedcorrectly.

Consulted with staff, management and external resources to identify appropriate training anddevelopment interventions that met emerging business needs such as coaching, finance training,clinical training, etc.Planned, organized, and marketed training events, and provided appropriate administrative support.Researched, developed and implemented training programs via leading and coaching operational work teams.Evaluated programs and return on investment.Recommended further training and development solutions.Made cost vs. benefit analyses and recommendations regarding training interventions.Maintained company training database and distributed reports as requested.