• Project Lead responsible for coordination and oversight of clinical data management tasks for one or more studies.• Ensure adherence to Global Study Operations-Data Management procedures and processes through oversight of quality, cycle times and metrics. • Provide oversight, mentoring, and coaching of FSP-based data managers to ensure clinical studies are executed with quality and consistency.• Communicate and escalate study level issues including processes, timelines, resourcing and performance. • Develop, review and implement controlled documents affecting Data Management.• Assist with preparation for inspections and provide responses to questions and findings from Regulatory Authorities and other audits.• Represent Global Study Operations-Data Management at program team meetings.• Participate in Data Management and cross-functional working groups including global network representation.• Provide therapeutic area and product knowledge and assist in the development of Data Element Standards.• Identify, champion, and support process improvement projects.• Lead electronic submission activities.

• Senior Data Manager responsible for multiple global Phase I-III vaccine clinical trials using InForm EDC. • Develop and maintain Data Review Plan Specifications, CRF Completion Requirements, Data Management Plan, non-CRF Data Transfer Specifications, Study Design Specifications, and Edit Check and Derivation Specifications.• Mentor and coach data managers in end-to-end processes within Clinical Data Sciences.• Perform oversight of CRO and FSP-based data managers.• Develop and deliver Investigator Meeting training related to data collection and InForm EDC entry.• Facilitate cross-functional team to identify and resolve data issues to expedite data cleaning.• Support protocol deviation (PD) review and collaborate cross-functionally to assess and document PDs.• Evaluate Risk-Based Monitoring (RBM) signals and recommend actions to the study team.• Conduct monthly audit of study-specific data management documents in the Trial Master File (eTMF) to ensure documents are filed contemporaneously to support submission and inspection readiness.• Evaluate and resolve data errors in Pinnacle 21 Enterprise to prepare data for regulatory submission. • Perform comprehensive review/reconciliation of CRF and non-CRF data, including data from third-party vendors, in accordance with the Data Review Plan.• Oversee data review, query management, and metrics reporting.• Conduct study-specific resource planning.• Identify, champion, and implement process improvements within Clinical Data Sciences.• In collaboration with the Clinical Data Scientists and Asset Leads, ensure operational excellence across all data management deliverables.

• Lead Data Manager for global Phase III oncology trial using Medidata Rave EDC.• Responsible for executing the Data Management Plan with high attention to detail, accuracy, and timelines. • Performed comprehensive data review using data listings and patient profiles.• Trained, led, and managed FSP staff responsible for assisting with routine data cleaning and listings review.• Collaborated with database programmers on database design and user acceptance testing.• Cleaned data for interim analysis and study close and performed database freeze and lock preparation procedures.• Trained CRAs and global study personnel on EDC, study endpoints, RECIST 1.1, and study procedures.• Worked closely with CRAs and medical monitors to identify and address negative data trends.• Managed and reconciled data obtained from third-party imaging vendor and central lab. • Represented Data Management within cross-functional clinical study team. • Created and maintained status reports for clinical study team and management review.• Performed medical coding per MedDRA and WHO-DDE dictionaries.• Managed and prioritized project deliverables per study timelines.• Conducted user acceptance testing (UAT).

• Managed Clinical Data Management Department of a non-profit clinical research consortium responsible for conducting Phase II-III oncology trials across 19 Colorado community-based clinical sites.• Trained, mentored and managed a team of data coordinators to ensure high quality data across 20+ active protocols for both National Cancer Institute Cooperative Group and sponsor-funded clinical trials.• Championed, planned, and implemented continuous quality improvement efforts throughout the organization.• Performed source data verification of eCRFs and source data review of clinical research charts.• Performed protocol feasibility and conducted protocol-specific training for clinical research staff. • Trained staff on EDC systems and data repositories used by NCI Cooperative Groups and Sponsors, including Medidata Rave and InForm.• Created, reviewed, and approved research SOPs.

• Streamlined clinical and commercial stability testing requirements, resulting in $2.5M cost reduction. • Directed a department of 20+ staff, including budgeting, forecasting, hiring, training, and performance management.• Planned, organized, monitored, and controlled all aspects of department responsible for design, execution, and evaluation of clinical and commercial stability studies in accordance with GMP, ICH/FDA guidelines and company SOPs. • Stability Quality System Owner and primary department contact with regulatory agencies during inspections. • Authored/reviewed drug substance and drug product stability sections of regulatory submissions. • Collaborated with global multidisciplinary teams to support global marketing applications and amendments. • Reviewed/approved analytical method validation protocols and reports, change control records, corrective and preventative actions (CAPA), deviations, SOPs, laboratory notebooks, stability protocols and reports. • Experience with selection, design, implementation and management of Laboratory Information Management Systems for stability studies and analytical data management.

• Supervised Stability Department responsible for design, execution, and evaluation of clinical and commercial stability studies in accordance with GMP, ICH/FDA guidelines and company SOPs. • Responsible for department hiring, training, and performance management.• Authored drug substance and drug product stability sections of Biologics License Applications and Marketing Applications. • Represented department on multidisciplinary global product development teams.• Responsible for document revision and control of product specifications.• Received Amgen ATLAS award 01/2001, 01/2002, 01/2003, and 11/2003 in recognition of outstanding teamwork, leadership, and achievement.

• Efficiently performed routine stability assays in support of stability and release testing of clinical and commercial drug products per GLP, GMP, ICH/FDA guidelines and company SOPs. • Planned, executed and evaluated clinical and commercial stability studies.• Designed, executed and monitored clinical stability studies to support intravenous drug delivery for Phase III oncology clinical trial.

• Initiated, monitored and evaluated stability studies of clinical and commercial drug products. • Authored Annual Product Reviews for submission to FDA.