Health Care Statistics @
Boston College Continuing Education Program
Dynamic Clinical Operations Manager/Subject Matter Expert with extensive experience in the biotechnology industry providing outstanding management expertise in research analysis of various therapeutic areas (nephrology, interventional cardiology, and peripheral vascular) within Clinical Review and Safety day-to-day operations. Creative problem solver with strong team-building skills, focused on efficiency and quality of work product, formulating policies and procedures, including
Dynamic Clinical Operations Manager/Subject Matter Expert with extensive experience in the biotechnology industry providing outstanding management expertise in research analysis of various therapeutic areas (nephrology, interventional cardiology, and peripheral vascular) within Clinical Review and Safety day-to-day operations. Creative problem solver with strong team-building skills, focused on efficiency and quality of work product, formulating policies and procedures, including Quality Assurance/Quality Control, and internal and external audits activities. Capable of improving profit margin through development and planning of human resources and continues process improvement programs, seeks to enhance effective hands-on experience, pursue new challenges, and provide outstanding services.
Clinical Operations Manager @ •Manages the Clinical Operations and Clinical Review and Safety personnel as required
•Conducts the hiring, firing, disciplining, and motivating of assigned staff
•Establishes/reviews SOPs and Guidelines relevant to the departmental and company activities
•Facilitates review of current processes and develops process change mapping where necessary to improve efficiency within Clinical Review and Safety department applying Kaizen Lean methodology
•Recruits physicians. Conducts related activities between Clinical Operations and Contracts to ensure that appropriate documentation is completed in accordance with SOPs, including, but not limited to, physician CVs, study Conflict of Interest and other pre-determined screenings
•Maintains meeting production and scheduling with input from the Project Managers and clinical team concerning event prioritization
•Addressed consistency in collection, processing and evaluation of Source Documents, Serious Adverse Events (SAE) and clinical events data. Responsible for Safety component of the Study Safety master file for assigned projects
•Participates in patient health information (PHI) verification process and collection of Source Documents/SAEs, in conjunction with the Project Managers, lead CRA and the Clinical Review and Safety Management
•Contributes to the creation and monitored the operations budget
•Develops, integrates, and implements Public Relations (PR) activities designed to enhance departmental service and company brand.
•Participates in the identification of departmental goals, and assists in development of the Marketing Tool and evaluating the progress in meeting the yearly goals
•Establishes the management Trial Master File (TMF) function within department for all active studies. Responsible for timely submission of compliant TMF to the Sponsor and for TMF process improvements. Initiates repeatable processes utilizing key technologies (cloud-based eTMF applications) From July 2013 to Present (2 years 5 months) Manager of Data Management @ Worked with Clinical Affairs, Medical Affairs, Database Development, and Biostats to provide reliable data to the sponsor.
• Managed, staffed, trained, and motivated a staff of department employees. Conducted regularly scheduled individual and group staff meetings of the Data Entry and Data Management area.
• Reviewed clinical trial data, and updated the clinical database.
• Generated and integrated queries for missing or discrepant data.
• Reviewed edit check output, CRFs and listings to identify missing or discrepant data.
• Designed CRFs through protocol review; developed DM Plan, and UAT.
• Monitored and evaluated the performance of the department using the statistical data elements from Monthly Financial Statements. Worked closely with Finance on the Data Entry departmental budget preparation. Provided Project Analyst with the budget update if needed.
• Identified deficiencies and logical inconsistencies found with problem data rejected from the clinical databases during data entry. Conducted the process for performing a quality control audit on a clinical trial database.
• Participated in maintaining timelines for assigned projects within Data Management and Clinical Review based on constant interaction with project personnel.
• Assisted Programming with the testing of new data entry programs. Uncover computer applications that are hampering production and monitor their resolution. Developed/revised/implemented new data entry Standard Operating Procedures (SOPs). Authored Project-Specific Guidelines detailing manual instructions to be followed for the data entry.
• Monitored Data Entry workflow to ensure the timely and accurate entry of all data. Ensured all Data Entry activities are complete prior to statistical analysis.
• Performed data cleaning including running range checks or validations and edit reports, resolving discrepancies, and entering of corrected data. From April 2001 to July 2013 (12 years 4 months) Data Technical Specialist @ Monitored the quality of data entry by evaluating the data into the database
• Created queries and Validation Error reports to identify and correct invalid data in MS Access databases.
• Resolved issues with data entry and validation systems to support the collection and analysis of clinical trial data at HCRI using VB 5.0 and MS Access.
• Developed and maintained a standard method for data entry Quality Control. Resolved document discrepancies using the tracker program. From March 1999 to April 2001 (2 years 2 months) Core Lab Research Assistant @ • Urgent film tracking, return and clinical site notification.
• Liaison with clinical sites regarding film status, delinquent films, Technician’s Worksheets etc.
• Performed data cleaning including running range checks or validations and edit reports, resolving discrepancies, and entering of corrected data. From February 1996 to March 1999 (3 years 2 months)
Master of Science (MS), Management in Research Administration @ Emmanuel Colledge Graduate Studies, Boston MAHealth Care Statistics @ Boston College Continuing Education ProgramCertificate, “Good Clinical Practices” in Clinical Investigation @ Boston University From 2008 to 2009 Certificate, Project Management @ Worcester Polytechnic Institute From 2000 to 2001 Certificate, Research Administration @ Emmanuel Colledge Graduate Studies, Boston MA Vera Buris is skilled in: Clinical Trials, CRO, FDA, Clinical Research, 21 CFR Part 11, Protocol, Biotechnology, EDC, Clinical Development, Regulatory Affairs, Data Management, GCP, Sop, Oncology, Lifesciences
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