PROFESSIONAL SUMMARY:

• Over 16 years of research experience working on all phases of clinical studies
• Experienced with Oncology Studies solid tumors and hematology
• Proficient in managing projects and interfacing with vendors
• Experience working on Oncology projects with the National Institutes of Health and the National Cancer Institute
• Familiar with government regulations and the importance of being able to understand their applicability to the pharmaceutical industry and the submission process.
• Experience developing training in various EDC platforms
• Proficient in writing data management documentation, training manuals and data flow processes
• Thorough understanding of budgets and algorithms
• Ability to communicate out of scope requests to the clinical project manager
• Coding of medical terms withdrawn from diagnosis in patient charts
• Proficient in Management responsibilities including resource management, performance management and hiring.
• Astute at planning, developing, implementing and delivering quality results in a timely manner
• Execution of the SDLC for implementation of acquired protocols for drug management systems.
• Execution of the life cycle development of DM Projects from Study Start up to Study lock
• Project Lead of IVRS systems for global drug supply management
• Management and development of SAE reconciliation training documents and process
• Site coordination, in - house monitoring, project management experience, and proficient with CTMS

TECHNICAL SKILLS:

Oracle Clinical RDC, SQL, Data Trak, Medidata RAVE, Inform, Registrat-MAPI, Remote Data Management, CDISC, Basic SAS, Clintrial, Microsoft Project, Documentum, Knowledgeport, J Review, Management of hospital/site data systems Logician, EPIC, CODE, ATHN database web tracker and CTMS.

PROFESSIONAL EXPERIENCE:

Confidential, Berkeley Heights, New Jersey

Senior Clinical Data Manager Medical Affairs (Consultant)

Responsibilities:

• Reviews synopsis/protocol and attends Synopsis Review Committee (SRC) meetings
• Lead studies in Non-Hodgkin's lymphoma and breast cancer.
• Leads DM study start-up and maintenance activities - CRF design/edit check specifications//external vendor specifications, CRF completion guidelines, (CCGs), coding, IVRS, etc.
• Leads development of site/investigator training materials and present at Investigator Meetings
• Leads Confidential team with User Acceptance Testing as applicable
• Leads SAE reconciliation
• Demonstrates ability to analyze data, share trends/observations with team members around results and relevant metrics
• Leads data review and query management
• Prepares the Data Management Plan and essential documentation
• Adheres to data standards and proper data validation processes
• Performs reconciliation of external data
• Leads database lock activities: inclusive of final SAE reconciliation/final data review, study decommission, etc.
• Lead/Participate in regular team meetings and provide input when appropriate
• Core study team member and primary contact for data management
• Provide input and assist in review/adherence to project timelines
• Provides oversight of vendor activities to ensure quality and timely deliverables
• Participates in CRO/external vendor selection
• Review Statement of Work (SOW)/contracts
• Provides CRO oversight of the data management functional activities and monitor progress and deliverables
• Ensures training on Confidential SOPs, if applicable
• Participates in writing/reviewing of functional SOPs/Working Procedures/Guidance Documents
• Leads/participates in department initiatives
• Ensures departmental companion groups (Programming, Coding, CDSI, etc.) are consulted appropriately on study decisions
• Trains Data Managers on Confidential standards and processes
• Liaise with cross-functional teams to provide data management deliverables to health agencies
• Participates in submission activities, if applicable

Confidential, East Hanover, NJ

Senior Clinical Data Project Manager Oncology (Consultant)

Responsibilities:

• Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards.
• Primarily responsible for multiple myeloma studies.
• Review and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data. Review and contribute to the preparation of protocols, CRF's and prepare or review/contribute to operations manuals.
• Organize / chair data management meetings. Support and assist clinical data managers, clinical data assistants for allocated trials.
• Manage Contract Research Organizations (CROs) contracted to perform data management functions.
• Travel when required.
• All other duties as assigned.

Confidential

Project Site Coordinator III/Data Manager

Responsibilities:

• Maintains updated versions of protocols, consent forms, and study forms, and study files
• Attain and verify informed consent.
• In-House Study Monitor responsibilities for Investigator Lead Studies (Sickle Cell Disease and BMT)
• Meet with Sponsor Clinical Research Associates for monitored visits.
• Web Tracker Administrator for Texas Children's Hemophilia and Thrombosis Center
• Registers patients on protocols conducted by the hematology team, as required by study assignment.
• Prospectively tracks information on internal and external study entrants regarding demographics and other issues.
• Completes Case Report Forms (CRFs) for internal (TCCC&HS) study entrants.
• Ensures quality assurance. Evaluates data to ensure that protocol required events took place and monitors the reporting of data for accuracy and completeness.
• Monitors internal and external data to ensure that the study is being conducted in compliance with the FDA regulations.
• Participates in regular meetings with the Principal Investigator to review study data.
• Maintains research charts for internal and external study entrants.
• Corresponds with personnel at external institutions to ensure that data for patients from outside institutions are obtained as specified by the protocol.
• Sends and maintains copies of written requests for incomplete, inaccurate data or outstanding data.
• Coding of all hematology patients seen in the Clinical Care Center
• Provide renewals and Study Amendments to IRB for approval
• Participate in feasibility meetings for new protocols.
• Manage the metrics for the hematology and oncology department as well as provide ad hoc reports to investigators and management for budget review.

Confidential, Houston, Texas

Principle Data Manager

Responsibilities:

• Assist / perform responsibilities associated with the acquisition, documentation, review, cleaning and processing of clinical data collected for investigational drugs, in global clinical trials, conducted both in-house and outsourced globally
• Run SQL queries to retrieve data within Oracle Clinical
• Relay information regarding data management status reports
• Create the Data Management Plans, Data Cleaning Plans, Quality Control Plans, Data Management Reports, and protocol deviation specifications
• Responsible for creation, review, approval and maintenance, of all required trial data management documentation (DMP, all applicable forms etc)
• Analyze metrics surrounding the activities associated with the acquisition, documentation, review, cleaning and processing of clinical data
• Interpret study timelines and prioritize workload appropriately, coordinating the activities of CDM trial team, typically CRF Designer, Database Designer, Clinical Data Associate, Data Entry Operators, Coding Specialist and SAS Clinical Programmer
• Facilitate global process harmonization with other i3 Data Management sites
• Ensure that data deliverables receive appropriate quality assurance reviews
• Responsible for Pancreatic and Liver cancer studies (solid tumors)
• Establish and coordinate the timely completion of the database lock procedures
• Ensure adequate preparation for internal and external database and data management audits, can respond knowledgeably and confidently to issues or questions that arise during audits
• Participate in budget review for projects, as well as, managing and reviewing contracts with vendors
• Evaluate and monitor departmental resources and plan resource allocation for all projects
• Send and/or communicates status reports to the client
• Report status of ongoing clinical studies to the senior management and/or sponsors Train data management personnel in following GCP guidelines and standards, as well as establish good working practices
• Manage projects (including but not limited to Alliance Projects) and the resources necessary for their successful execution
• Assist in the development of business development proposals related to Data Management
• Assist or lead establishing and maintaining divisional policies and procedures (e.g. Standard Operating Procedures and Working Practices)
• Maintain effective employee relations by ensuring consistent business practices within the division
• Document CRF completion guidelines and instructions and presents at investigator meetings
• Interact with other department heads to ensure process integration
• Available to staff as mentor/trainer in all processes within i3 Data Management

Confidential, Sugar Land, Texas

IVRS Project Leader

Responsibilities:

• Primary contact for clients and drove the success of the project by adhering to ICON SOPs and appropriate regulations
• SDLC Management of Interactive Voice Response Systems from start up thru completion of drug dispensation of subjects
• Managing call center calls and SAE reporting from sites to the call center
• Development of training materials for the call center staff
• Responsible for management of drug supply systems and direction and training of drug analyst assigned to studies
• On-call management of maintenance of global drug management systems
• Created SQL queries in order to run daily metrics within SQL Server
• Manage drug supplies utilizing SQL queries
• Transfer data from one proprietary database to another using SQL
• Ensure client satisfaction in addition to providing supervision to other members of the team
• Acted as the Sponsor’s main contact person in all matters regarding ICON services including day-to-day management of studies
• Provided Sponsors with regular study management reports, reporting any deviations by a site from clinical study specific instructions, and handling any clinical study specific requirements; forecasting and communicating study progress in a responsible and professional manner
• Performed QC on the Investigator Manual and any amendments to an assigned study
• Responsible for preparing clinical study specific study files ensuring that all appropriate documents were properly maintained
• Prepared clinical study specific presentation material and attending / representing ICON at Sponsor Investigator Meetings
• Interfaced with Business Development for pro-active monitoring of study budget
• Responsible for setting the timelines for and monitoring the progress of shipment requests for storage samples including data verification
• Responsible for ensuring all necessary documents were archived at study closure
• Served as technical /database support for team members
• Scheduled regular meetings with the team for study progress updates and to monitor performance of the team members
• Updated the Vice President, Client Services on studies’ progress via regularly scheduled meetings
• Managed, coached and trained all staff in Project Management, Protocol Set-up, and Site Services

Confidential, Smyrna GA

Senior Clinical Data Manager

Responsibilities:

• Performed Data project management responsibilities associated with the acquisition, documentation, review, cleaning and processing of clinical data collected for investigational drugs
• Managed both in-house and outsourced projects and CROs
• Designed Case Report Form according to the Clinical Protocol
• Created the Data Management Plan, Data Cleaning Plan, and protocol deviation specifications
• Created Quality Control Plan describing appropriate standards for acceptable data quality levels, methods for quantifying data quality and practices to assure data quality
• Created the Data Management Report
• Analyzed metrics surrounding the activities associated with the acquisition, documentation, review, cleaning and processing of clinical data
• Interpreted study timelines and prioritized workload appropriately to study personnel
• Coordinated the activities of CDM trial team, typically 1 CRF Designer, 1 Database Designer, 1 Clinical Data Associate, 3 Data Entry Operators, 1 Coding Specialist, 1 SAS Clinical Programmer and 1 Oracle Clinical Programmer
• Participated, as data coordination representative, in global and local Clinical Data Management initiatives, to contribute to the continuous improvement of the processes and technologies utilized within the department
• Provided ongoing study training and conducted presentations at Investigator meetings

Confidential, Marietta, Georgia

Senior Project Data Coordinator (Consultant)

Responsibilities:

• Supervised and trained Data Analyst and Data Entry Operators in study specific project tasks
• Developed study specific data handling guidelines/validation guidelines and new procedures assist in the development of edit checks
• Participated in the interview process of prospective job candidates
• Interacted with sites/clients to resolve data related issues
• Worked closely with the Clinical Project Manager to coordinate the data management processes and to ensure that project deadlines are met
• Monitored timelines and project budgets in order to insure that projects are completed on time and on budget
• Recommended Change Orders when out-of-scope components of a project become apparent, point person to ensure the quality of project databases
• Created CRF according to protocol, and management and in corporation of data from outside vendors
• Developed and maintained the data management plan ensuring that it accurately reflects the data procedures used for assigned projects
• Oversaw the generation of quality control reports including ensuring the quality and consistency of queries,
• Appointed to develop the department training Manual.

Confidential, Alpharetta, GA

Project Coordinator (Consultant)

Responsibilities:

• Managed assets by providing timely and accurate updates to MRO system to facilitate accurate project tracking and reporting
• Monitored and analyzed lease end dates as well as identifying individuals and deployed assets
• Ensured MRO system is reconciled with data records accurately
• Managed daily schedules of technicians
• Evaluated reports on a weekly basis

Confidential, Rockville, MD

Clinical Data Coordinator

Responsibilities:

• Managed the day-to-day data management operations of assigned protocol(s), including coordination of team member activities
• Managing studies for COPD, non-small cell lung cancer, and hyponatremia
• Managed vendors (e.g. CRO, EDC Vendor, central lab), the review of tables and listings for data accuracy and completeness, review of study reports for assigned protocol(s)
• Managed data acquisition from external sources, e.g. central laboratories and other CROs
• Coordinate with Scientific Programming staff to ensure proper development of databases, data entry screens, and edit check programs as well as assist in CRF and ecru Design used by CRO monitors
• Track and manage data cleaning activities of assigned studies to meet agreed timelines, budget and resources
• Responsible for supervising data cleaning functions and generating statistical reports
• Liaise with in-house CRAs, EDC Vendors and CROs on data collection and data quality issues
• Training the CRO monitors and site personnel on Electronic Data Capture