Supervise and mentor assigned Clinical Data Management staff. Manage project busgets, timelines, resource planning, and overall quality of data management services of assigned projects/sponsors.

Currently, oversees several phase 1 and 2 CVMED studies for Pfizer's BioTherapeutic/Research Group.

Acting as a Program Data Manager (PDM) for Pfizer, Inc. in the 3b/4 Unit in Europe on over 15 projects• Single point of contact for Protocol Project Manager • Accountable to the Project Manager for all data management conducted externally at all FSPs, CROs and other offshore partners.• Oversight includes ensuring standardization, quality, cost effectiveness and timely clinical trial data across clinical program.• Ensure the consistent use and application of standards and data quality and consistency across programs and repositories.• Responsible for determining if non-CRF data will be databased in OC, develop the Data Management Oversight Plan.• Approve the CRF/eCRF completion guidelines, finalize mock CRFs and specify book layout.

Acting as the Lead Project Data Manager on assigned adult and pediatric projects for BMS-MI, along with management of contract Data Managers in the department. Indications and areas of study include Myocardial Perfusion Imaging, Kawasaki Disease, Percutaneous Coronary Revascularization, and Intracoronary Temperatures.•Manage two contract Data Managers •Develops, or is primary reviewer of Case Report Form design, EDC screen design, data review guidelines, edit check specifications, data quality processes, coding guidelines, and database design according to SOPs, CDISC standards and protocols.•Work with other project managers from Clinical Research, Medical Affairs, Regulatory Affairs, Project Management, and Sales and Marketing to determine, execute, review, and advise on appropriate data management applications for each project assigned.•Write and review data management and departmental SOPs, forms, work instructions, and guidelines.

Acting as the Lead Data Manager on assigned projects for Genzyme Biosurgery. Indications and areas of study include Adhesion Barriers in Abdominal and Pelvic Surgeries, Dermal Fillers, Lung Cancer and Pulmonary Surgery, Ischemic Heart Failure, and Osteoarthritis of the Knee. •Work with EDC vendors and EDC manager to design EDC screens and edit checks.•Maintain EDC database•Plans, coordinates, tracks and manages data management tasks for clinical studies outsourced to CROs.•Review and approve Case Report Form design, data review ground rules and edit check specifications, and database design according to SOPs, CDISC standards and protocols.•Work with other project managers from Clinical Research, Medical Affairs, Regulatory Affairs, Project Management, and Sales and Marketing to determine, execute, review, and advise on appropriate data management applications for each project assigned.

Responsible for managing two Phase IV transplantation trials with a combined enrolment of over 700 patients. In addition to data review also responsible for training new team members, task assignments and QC. Involvement in project management tasks such as budget and timelines.•Coordinated activities to lock databases for 11 interim analyses.•Managed case report form flow and query turnaround with client, monitors, and site coordinators.•Primary client contact for data management issues.•Coordinated communications between data entry, database services and data management.•Reconcile Serious Adverse Events with client CS&E database.•Generated metrics reports for all protocols.•Assisted Project and Line managers in resource management.•Lead Lessons Learned forums for PAREXEL and client managers.•Mentored new data managers.•Assist and review budget activities and out of scope planning.