-Provide clinical study level data management oversight of outsourced clinical trials for phase I / II studies including: project management, vendor management, coordination of internal reviews, and approval of deliverables-Oversee database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards, ensuring complete, correct and consistent clinical data and outputs-Act as liaison with CROs, third party data vendors, and EDC vendors-Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed, and communicates project status and issues-Author/review eCRFs, CCGs, and Data Management Plans-Review data analysis listings and report on performance and quality; review clinical data within studies and across programs for trend analysis-Accountable for external data vendor documentation, management, and reconciliation-Assist as needed with clinical documents such as clinical protocols, Investigator Brochure updates, annual reports and status updates-Collaborate with Clinical Operations to ensure the data management component of the eTMF is maintained appropriately throughout the trial

-Lead data manager on rare disease trials, managing trials in various stages through planning, start-up, conduct, database lock, and regulatory submission support-Perform CRO and TPV oversight of clinical data management activities -Establish and maintain strong working relationships with CRO and TPV partners to ensure efficient communication and alignment on data management processes -Develop and maintain study-specific documentation such as Data Management Plans, eCRF specifications, CRF completion Guidelines, Data Transfer Specifications, and Database Audit and Lock Procedures-Ensure all clinical data management activities comply with relevant regulatory requirements and industry standards-Work collaboratively with database programmers and cross-functional team members to design eCRFs and edit checks-Conduct comprehensive data reviews to ensure accuracy, consistency and completeness of clinical trial data-Actively participate in multiple cross-functional team settings to ensure the effective delivery of assigned project milestones -Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines-Lead, coordinate, and perform UAT tasks for complex studies-Manage queries and trends to ensure data completeness and integrity-Participate in the development, review and implementation of SOPs and associated documents impacting data management -Ensure archiving of study databases and related documents

• Responsible for start-up activities, database maintenance, and database finalization for assigned clinical trials. • Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials. Data includes, but is not limited to; case report form (CRF) data, lab data, biomarker data, and patient reported outcomes.• Supports the project management of all clinical data management activities including project planning, initiation, execution, change control, and closing. • Performs risk management identification • Ensures trials meet the requirements for quality data collection and validation• Interprets the clinical protocol from a clinical data management perspective.• Provides clinical data management input into trial design, ensuring operational feasibility.• Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.• Facilitates assessment and assists in processing of standards and change requests.•Participates and manages trial-level data quality and completion of database lock and post- database lock activities• Monitors overall status and quality of data being collected during the in-life portion of a trial.• Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.• Ensures timely archival of trial data and documentation.• Decommissions clinical data management technologies in a timely manner.

• Initiate, lead, and document all CDM activities in the startup, maintenance, and closeout phases of assigned studies. • Ensure CDM documents and plans (i.e. CRF design, UAT plans, DMP, Edit Checks, SAE reconciliation, Coding Guidelines, Data Listing Review Plans, and startup and lock checklists) have been drafted, reviewed, and approved by the appropriate members of the clinical study team. • Ensure GCP and GDP standards are being followed for CDM activities throughout the study lifecycle.• Collaborate with the CRO and the third party vendors to ensure outsourced data management tasks remain on target according to project timelines and within budget.• Communicate CDISC standards to study team members and work collaboratively to develop an efficient and effective eCRF design. • Lead cross-functional discussions to define data handling, data flows and database design requirements. • Plan and perform user acceptance testing of the clinical database. • Define and manage CDM timelines to meet deliverables on time and within quality expectations of the study.• Collaborate with internal and external expertise areas to ensure alignment on data cleaning activities, timelines and deliverables. • Host internal and external meetings as needed to obtain team feedback of CDM key deliverables, activities and timelines. • Generate and disseminate project status reports to management as needed to monitor the status of clinical data entry, data collection, and data cleaning activities being performed on the study. • Ensure EDC user account requests across studies are being maintained and tracked. • Manage CRO/data specific vendor activities, timelines, and budgets. • Participate in data management initiatives such as evaluate technology vendors (i.e. EDC, analytic tools), author and review guidance documents/templates, and establish data collection and reporting standards. • Oversee database lock activities and archiving study data.

- Lead Data Manager on multiple Phase II and III Smoldering Multiple Myeloma Clinical Trials- Responsible for document creation and revision including Forms Completion Guidelines, Data Management Plans, and Work Instructions for various Myeloma trials. - Assist in conducting training for new hires on protocols, EDC, and data management procedures. - Collaborate with cross-functional teams to ensure forms, protocols, and database complies with GCP and company standards.- Responsible for User Acceptance Training for studies in development.- Maintain all responsibilities from Clinical Research Data Associate I position.

- Quality controlled patient charts to ensure adherence to ECOG-ACRIN protocols/guidelines and data accuracy. - Verified patient eligibility and study compliance utilizing Medidata Rave.- Utilized study specific Data Management Plans, Work Instructions, and SOP’s to review site reported data elements, query site contacts for resolution of discrepant data points, and resolve answered queries. - Reviewed treatment information, evaluate response to treatment, and ensure follow-up and survival data are accurately coded and updated in the database in a timely way.- Prepared patient charts for study chair review and biostatistician analysis under strict deadlines. - Performed serious adverse event reconciliation between Medidata Rave and the National Cancer Institute's safety database.- Ensured follow-up and survival data are accurately coded and regularly updated in the database. - Provided daily support to member sites about study protocol.- Reviewed and provided feedback for protocols in development.

-Collected, organized, and analyzed patient data for departmental reports and presentations-Assisted staff in evaluating the performance and effectiveness of new programs and initiatives-Actively participated in weekly administrative team meetings-Conducted research and assisted with initial assessments for areas of possible expansion-Utilized National Research Corporation Health platform in managing patient experience data, concerns, and responses-Analyzed the current healthcare landscape of the service area and identified possible areas for improvement in access and delivery

-Responsible for collecting, organizing, and analyzing data concerning nationwide vaccine mandates and trends -Collaborated with Dr. Todd Olszewski to write a chapter of Across the Aisle, a book on Democratic and Republican views of contemporary health issues expected to be published in the spring of 2020

-Assisted in following the growth and development of at-risk infants-Responsible for collecting infant history through parent report, following outlined age appropriate criteria -Recorded medical, neurological, developmental, and psychological findings as dictated by the licensed provider -Gained basic working knowledge of Epic Electronic Health Records-Developed interpersonal, communication, and problem solving skills