• Oversee vendors and manage clinical data management workflow for global development programs ensuring all necessary data quality control measures are in place; manage deliverables across multiple studies and be responsible for all vendor(s) oversight for outsourced DM activities.• Assist with clinical data related vendor identification through development and distribution of RFI/RFP and bid defense discussions in collaboration with cross-functional partners. • Participate with cross-functional partners, in the development of clinical data related to key performance indicators (KPIs) and key quality indicators (KQIs) to build into contractual agreements.• Review of clinical data related documentation including clinical protocols, Data Management Plans (DMPs), electronic Case Report Forms (eCRFs), Data Transfer Plans (DTPs), Data Management reports, eCRF Completion Guidelines, etc., liaising with colleagues in other functions to ensure alignment with high quality. • Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed to regulatory agencies. • Oversee performance of external vendors responsible for clinical data deliverables (e.g., UAT, query quality, clinical data transfers, database cleaning, database locking and archival, etc.); ensure quality completion of all clinical data related deliverables.• Ensure all clinical data is collected, handled, transferred, stored via secure and authorized methods, ensuring compliance with General Data Protection Regulation standards and local privacy requirement standards including identification of any systems or processes necessary to fulfil requirements.• Manages internal staffing and performance management, including hiring, training, coaching and performance reviews of staff.• Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, and tools.

• Responsible for oversight and delivery of all Data Management related activities for Phase 2 and 3 studies• Oversee CRO Lead Data Managers and Data Management activities to ensure data is complete and of quality for analysis and delivered within study timelines• Review all study related documents from the Data Management perspective for accuracy and completion, which includes but is not limited to Protocols, Study Timelines, CRFs, CRF Completion Guidelines, Medical Monitor Plans, SAE Reconciliation Plans, DMPs, and DTPs (including 3rd party vendors)• Hold meetings (weekly or monthly) with 3rd party vendor DM representatives and CRO DM team to ensure any outstanding issues are resolved and to ensure scheduled or unscheduled transfers are complete and on track for delivery as required• Perform database and edit check UAT to ensure accuracy and completeness prior to database release to production. This is also done for any needed migrations for database or edit check updates• Hold weekly meetings with all Lead Data Managers to ensure timelines and deliverables are being met, to help mitigate any potential bottle necks and to escalate any issues identified for resolution or assistance if needed• Provide Data Management related metrics and general updates for Bi-Weekly GDT and weekly CST meetings for all assigned studies• Responsible for overseeing the generation of Hyperlinked CRFs and eTMF archiving for CSR generation and regulatory submissions• Helped create and present training materials for CRAs and IORA members for data entry into RAVE• Review project plan times to ensure Data Management required activities listed and within the expected durations form study start up to study close out

• Data Management Project Lead responsible for oversight of all data management related activities for assigned studies• Currently assigned 5 studies which include: 2: Phase 0 Device Studies (Apple Watch/App/Alexa), 2: Phase 1 FIH studies (inflammation), and 1: Phase 1b/2a study (SLE/Lupus)• Oversees FSP (Functional Service Provider) Lead Data Managers for assigned studies to ensure DM activities are completed, in line with study timelines, and to ensure data quality and consistency across the Amgen portfolio • Responsible for the review of study related documents from the Data Management perspective, which include Protocols, Study Timelines, CRFs, CRF Completion Guidelines, DMPs, DTPs, IXRS documents (URS and BR) to ensure consistency with Amgen standards• Holds weekly one on one meetings with all Lead Data Managers assigned to studies to ensure timelines and deliverables are being met, to help mitigate any potential bottle necks and to escalate any issues identified for resolution and or assistance if needed• Reviews all DM related slides and metrics for weekly and bi-weekly CST meetings to ensure they clearly represent current DM activities, issues and metrics are accurate• Runs weekly metric reports to track the progress for all ongoing studies to ensure data is being collected and cleaned as required• Reviews study timelines to ensure all required DM activities are listed and within the expected durations• Subject Matter Expert (SME) for post locking activities, which include eArchiving and Hyperlinking of CRFs submitted to regulatory authorities• Responsible for the tracking of studies which require eArchiving or Hyperlinked CRFs and participated in the review and update of eArchiving and Hyperlinking related SOPs, Forms and Process Maps

• Provided Data Management oversight and guidance to the CRO responsible for data management activities in a 100% outsourced model for 3 Biosimilar Phase 3 studies (RA, PsO and an OLE)• Responsible for the review of study related documents which included Protocols, CRFs, CRF Completion Guidelines, Edit Check Plans, DMPs, DTPs, DTURSs and Hyperlinked CRFs for SOIs and Non SOIs subjects• Held weekly one on one meetings with both LDM and Clinical Study Managers for each study to ensure study timelines and deliverables are being met and if needed escalated issues identified• Attended weekly CST meetings as the Amgen data management representative for studies assigned • Provided guidance to the CRO responsible for all data management related activities, to ensure data quality and consistency across the Biosimilars portfolio• Provided the Amgen study team with weekly AE listings and ad hoc requests for datasets which enabled team members to perform data review in order to ensure data quality• Responsible for the creation and execution of Data Quality Review Plans for each study which required data review on a rolling basis and prior to any study deliverable to ensure data was cleaned as expected and fit for purpose • Created JReview listings to review data sets per the Data Quality Review Plan and performed data reconciliation of lab data, box ID numbers and package lot numbers to identify any potentially missing data• Attended Face to Face meetings with CRO cross functional team members for study Kick Off Meetings as well as post study Lessons Learned

• Managed 21 Early Development studies from start up through close out and ensured accurate on-time delivery of data• Oversaw 15 different Lead Data Managers, including internal and external Functional Service Provider staff• Provided guidance and mentored Lead Data Managers regarding Amgen processes and CDM best practices on multiple PH0, FIH, PH1 and PH1B studies• Assessed priorities, resources, and progress on a regular basis to ensure CDM deliverables were met• Managed and reviewed all documents for assigned studies including Protocols, Amendments, Case Report Forms, Data Transfer Plans, Data Management Plans, Study Definition Matrix and Scopes of Work• Managed all data management study related activities of an external Functional Service Provider• Worked with both Central and Local Laboratory data including potentially unblinding data• Participated in meetings with FSP Team Members, Clinical Study Teams, and Global Development Teams• Guided CDM activities for assigned Products and ensured consistency across the program• Member of ECG CSS FMT as the CDM representative for Early Development

• Facilitated data management activities for up to 4 studies simultaneously; including CRF development, database design and UAT testing, DMP creation, and oversight of CRO activities• Ensured CDM procedures and processes were adhered to and meet business needs• Created or reviewed Case Report Forms, Data Transfer Plans, SEC Documents and Data Management Plans• Ensured all study timelines with regards to start up, snapshots and close out were met• Participated in Clinical Study Team meetings and provided study status updates• Managed all data management study related activities of an external CRO• Coordinated CDM activities for assigned study teams

• Lead Data Manger of multiple late phase Cronh’s Disease studies (2 Phase III and a Phase II)• Managed all DM activities including discrepancy management functions• Trained all CRO staff members on Oracle Clinical Discrepancy Management using EDMS• Created and maintained Data Management Plans for all studies which consist of Data Entry Guidelines,Data Validation Procedures, Manual Edit Check Procedures, SEC documents• Created CRFs and CRF Completion Guidelines for Phase III CD studies• Performed both SAE and Lab Reconciliation for Phase III and Phase II protocols• Manually reviewed clinical data listings for quality, content, and format for all studies• Developed dirty and clean subject data packets for the testing of database set-up, programmed edit checks and data entry• Developed procedures and documents for tracking data management timelines and activities such as: CRFs Expected/Received Reports, DCF Status Reports, Audit-issues/Resolutions Listings

• Trained and coordinated CRO data entry staff for 2 Virology protocols• Managed all discrepancy management activities on 5 Virology protocols simultaneously• Created and maintained a Self Evident Correction document to minimize query generation• Coordinated and managed subject binder audits for 7 virology studies in preparation for database lock• Drafted and tested data validation and derivation procedures for multiple virology protocols • Developed subject data packets for the testing of data entry screens and database set-up• Assisted in the creation of new data standards for unique CRF pages• Generated CRF Completion guidelines to maximize data quality• Managed study documentation of validation procedures to satisfy QA regulations• Trained, mentored and coordinated daily activities of data entry staff