OF QULIFICATIONS AND CAPABILITIES 15 years of experience in maintaining quality control of phase I, II, and III clinical research trials including GCP/ICH guidelines and FDA regulations. Proven resourcefulness and problem-solving skills to consistently deliver enhanced research and production results. Team player dedicated to continuous quality improvement and exceeding the bottom-line objectives. Led Quality Compliance team of Quality assurance specialists Supervised team of data managers supporting 50 NCI clinical trials Quality control of data on CTMS and CDUS studies (CTEP) Provided data quality control for Astrazeneca studies on the CRS contract Provided training for contract employees, including CRAs and data management staff on protocol requirements, Quality Assurance procedures, ICH/GCP guidelines, FDA Title 21 CFR 50 - 56, 312, and DHHS Title 45 CFR 46, data entry/discrepancy management requirements in database. Expert knowledge of medical terminology, clinical diagnostic procedures and main approaches in cancer treatment and anti-cancer drug development. Strong organizational, analytical, and problem-solving skills. Strong presentation skills. Proficient in Oracle Clinical, PDMS (4th Dimension), Oracle Discover, Peoplesoft, MS Word, MS Excel, MS Power Point, MS Access, MS Outlook, and Imedidata RAVE, and Inform RESEARCH & PROFESSIONAL EXPERIENCE Peraton Bethesda, MD * Clinical Data Management Supervisor July 2014- Present Manage and oversee clinical operational activities that are part of the branch's broad national program of clinical research through appropriate management of regulatory requirements and oversight activities. * Leading a team of 3 Regulatory Specialist to activate and manage over 30 clinical in the field of genitourinary, and Women Malignancy oncology trials. Conducts new hire training and performs annual performance evaluations. * Develops and maintains team-specific CDM methods and SOPs of data entry, data abstraction, data validation, and reporting and analysis. * Accountable for the coordinated management of multiple projects directed toward strategic business and other organizational objectives. * Conduct ongoing meetings with staff to access workload and monitor the status of projects for timeliness and to anticipate future needs and the possibility of work reassignments. Ensure discussions and decisions lead toward closure. Kept team focused and on track. Provide guidance to the staff based on upper management direction. Performs quality control procedures. Assists in audit and monitoring activities both in house and outside monitoring by Quintiles CTEP, and FDA Ensures CRFs are processed, logged, and tracked in accordance with CRF processing instructions. * Ensures timelines, audit schedules, and other milestones are met. Assists in the maintenance of study files and documentation. * Interface with regulatory authorities and sponsors throughout the clinical trial to ensure compliance to FDA related and Good Clinical Practices (GCP) regulations in conduct of clinical research at the cancer center, and external sub-sites. * Develop study timelines for rapid activation of clinical trials. Coordinate the development of the protocol, manual of operations, data collection forms and consent forms for Data Coordinating Center (DCC). * Works with DCC and FDA to prepare applications and assure that all components of submission conform to NCI policy and FDA regulations. Organize and schedule network steering committee meetings. * Training and mentoring new hires and research community on regulatory policies and institutional procedures. * Responsible for effectively initiating, planning, estimating, forecasting, coordinating, controlling, managing and delivering all activities for projects and related release initiatives. * Manage the implementation and execution of financial operations. Review and manage expenditures to release for appropriateness and compliance with regulations. Monitor weekly and monthly budget expenditures and reconcile to financial reporting receive, gathere, and compile data receive for effectiveness and efficiency for submission to other organizational components. Worked on multiple projects in a fast-driven environment with weekly releases Prepare written statements of work and justifications when needed * Provide management advisory services to officials that are complex and dynamic in nature and training guidance to staff members on the principles, practices and techniques of projects. * Harris Orkand Information Services Falls Church, VA Quality Control Specialist/ CRA- NCI/ NIH Contractor July 2004 - July 2014 Reviewed data on phases I, II, and III oncology clinical trials for multiple branches of the National Cancer Institute (NCI). * Ensured timely and accurate collection, analysis, and reporting of trial data according to GCP/ICH guidelines and the standard operating procedures (SOPs). * Performed quality control procedures for data elements ACES, Oracle Clinical database, and paper Case Report forms (CRFs) prior to submission to monitoring agencies. * Generated complex biweekly and monthly reports that identify trends and sentinel events attributable to system, personnel and clinical issue for staff education and training purposes. * Reviewed data on eCRFs, test validation and discrepancy management procedures in Oracle Clinical database for CTMS and CDUS submission, and creates complex reports using Integrated Review. * Educated and trained data management staff on corporate SOPs, understanding protocol requirements, quality assurance procedures, GCP/ICH guidelines, FDA Title 21 CFR 50 - 56, 312, DHHS Title 45 CFR 46 data entry /discrepancy management requirements in multiple databases. Evaluated and recommended policies and procedures. Determined road map dates based on metrics and priorities. * Ensured contractors receive all items required in the contract/task order to be furnished by the Government. * Reviewed and responded to the monitors Queries and support Research team for audit preparation. * Atlis System Incorporated Silver Spring, MD Project Supervisor September 1997 - July 2004 * Performed quality assurance checks and implemented quality improvement process to maintain data integrity. Managed MESH database for NLM. Coordinated and supervised data entry and document analysis. * Conducted ongoing meetings with staff to access workload and monitored the status of projects for timeliness and to anticipate future needs and the possibility of work reassignments. Ensured discussions and decisions lead toward closure. Kept team focused and on track. Provided guidance to the staff based on upper management direction. Provided quality assurance services for NLM database. Organized training of new employees and performed 6-month evaluations. Managed 30 editors and proofreaders. * Aspen Systems Incorporated Rockville, MD * Litigation Support Specialist February 1994 - September 1997 * Coordinated and managed data entry and document analysis. Organized training of new employees and managed 35 paralegals and coders. Performed the annual employee review and managed timesheets. * Performed quality assurance checks and implemented quality improvement process to maintain data integrity. * EDUCATION & TRAINING EXPERIENCE

Highlights:

• Accenture FOUNDATION
• Analytical Skills
• Audit
• Cancer
• Clinical Research
• Communication Skills
• Compliance
• Data Entry
• Data Management
• Data Quality