Lead strategic and operational aspects of data management. Ensure data governance and standards. Oversee CRO partnerships, optimze data collection process and regulatory compliance.

- Oversight of clinical data management activities for the Atara Multiple Sclerosis program- Manage data team and activities for all clinical trials as well as the design, review, and validation of the clinical database to deliver data for analysis and submission as part of a regulatory filing.- Implemented Risk Based Quality Management in data management- Delivered on time data snapshots to support Interim and Primary Analysis, DSURS, Safety Reviews, publications, conference posters and publications- Lead the creation of the data analytics team implementing Tableau Visualizations to assist with medical data review- Primary interface with CROs to organize on-going data review throughout the study to ensure timely identification and correction of errors or discrepancies. - Development of metric reports to manage key performance indicators on vendors and data entry/cleaning - Routinely communicates site data concerns/issues with clinical operations team and CROs to ensure collaboration toward resolution.- Worked in coordination with statisticians and programmer/analysts.Third Party lab and imaging vendor oversight of creation and delivery on data transfer agreements- Participate in frequent inspection readiness drills

- Across all data acquisition solutions, ensure all data received is correctly processed, distributed, and accounted for throughout solution - Collaborate with CDE&I Team, IT solution and support teams, and associated business partner teams to ensure daily operational control of clinical data exchange - Maintain, monitor, and publish operational metrics to demonstrate adequate control of data within the capability- Proactively identify data anomalies and issues for externally submitted clinical data and seek variances in expected patterns which may indicate undiscovered issues - Trouble shooting issues regarding incorrect, incomplete, or missing data - Enable actionable follow up with external business partners to re-mediate observed issues when appropriate - Assist in overseeing operational break/fix activities for production operations - Provide in depth analysis on quality issues leading to strategic remediation of underlying issues - Continual identification of opportunities to streamline and automate operations. - Assist in developing knowledge base content. Insure knowledge base is up to date and lead continuous effort to provide quality tested content and feedback. - Manage Data Analyst's- Provide subject matter expertise in solutions

Clinical Data Management, ManagerProject Lead Data Manager, Risk Management Trial (REMS), Aranesp, Epogen and Procrit• Data Management representative on cross-functional team consisting of Sales Operations, Marketing, Scientific Affairs, Regulatory and Legal• Ensure that study timelines and milestones are met• Ensure quality day via manual clinical data review and edit checks throughout the study lifecycle• Proactively identify potential study issues/risks and recommends/implements solutions• Facilitated documentation of the Data Management Plan, Standard Operation Procedures, BusinessRequirement Documents and File Interface Agreements• Relationship management for multiple vendor’s including RFP, SOW development and change management• Presentations to Sr. Management identifying trends in the data to drive program decisions• Lead cross-functional team on the system architecture re-build; gathered business requirements• Lead the data cleaning process, track and resolve queries for the study lifecycle, close out and database lockprocedures in collaboration with the Lead Team Members (LTM)• Bi-Yearly FDA Assessment Reports – Author data management sections and collaborate with Statistician onprogramming of data tables• Provide direction to programmers on development of ad-hoc reports• Support FDA questions via data analyses and areas for program management improvementProject Lead Data Manager, Phase 2 & 3 Unblinded Data• Managed database locks/snapshots for Evolocumab filing within corporate timelines• Relationship management with Laboratory vendor’s to ensure result accuracy and validation process is beingimplemented according to documented agreements• Ensured quality data via manual clinical data review and edit checks• Partnered with Clinical Scientist on review of primary and secondary endpoint lab data prior to database locks• Development of TIBCO Spotfire visualizations for review of outliers

Data Analytics• Designed and maintained regional % to plan monthly sales reports and quarterly ranking report from vials shipped to track sales performance• National/Regional/Divisional sales growth analyses on a monthly basis for territory strategic planning• Medical Education Program MetricsSales Operations• Task force member for Sales force automation tool development (Salesforce.com)• Monitor budgets at National/Regional/Divisional level • Compliance expert for field sales regarding Pharmaceutical Industry standards

Sales management support for Oncology product launches. Sizing, Territory Alignment, Incentive Comp and Recruitment

Sales management support for Oncology product launches. Sizing, Territory Alignment, Incentive Comp and Recruitment

Data Analytics• Supported Sales Management with designing sales reports for predictive analysis to drive regional management decisions• National/Regional/Divisional sales growth analyses on a monthly basis for territory strategic planning• Medical Education Program MetricsSales Operations• Task forces member for sales force automation tool development (Salesforce.com)• Monitor budgets at National/Regional/Divisional level • Compliance expert for field sales regarding Pharmaceutical Industry standards Vendor Management• RFP and SOW development• Manage vendor to ensure resources align with business priorities and are delivering according to plan

Clinical Trial Management • Project team coordinator for the start-up, maintenance and shut down of t-PA (ATLANTIS) clinical trial• Developed and managed databases for all investigator study payments, contact information and IRB documents • Validation of Statistic data tables for the Biologic License Agreement filing for TNK• Partnered with statistical programmer on study publications • Managed the generation and renewal of consultant and vendor contracts • Planned International Advisory Boards, Investigator meetings and Steering Committee meetings