Sandra B. Email & Phone Number

United States

Remote

Protocol Data Manager for Bristol-Myers Squibb: Coordination of DM and cross functional working groups to ensure clinical projects are executed with quality and consistency. Actively monitor progress to ensure delivery to set scope and timelines.

Raleigh, North Carolina

Provide immediate results in preparing Phase IIIa oncology megatrial data for interim analysis.

Aerotek Contractor To Lineberger Comprehensive Cancer Center

Manage multiple, complex Phase I-II trials throughout entire lifecycle. Create eCRF’s and study calendar from protocol, lead approval process. Quality oversight of remote data capture, data cleaning and preparation for abstracts and manuscripts. Develop solutions where procedures were not established and techniques had not been identified. • Introduced Work Instructions and guidance on enhanced tools utilization, querying, GCDMP’s. • Advanced the automation and standardization of data validation across studies. • Optimized data cleaning reports working closely with Applications Analyst. • Composed group's first eCRF Completion Guide.

Morrisville, North Carolina

DM point of contact on Phase I oncology study, represent DM in Sponsor meetings. Review eCRFs, data listings and database to ensure conformance to the protocol and data management plan. Perform data cleaning activities. Contact vendor labs to coordinate data transfer. Maintain appropriate DM documents for Trial Master File. Monitor project scope. • Took over responsibilities for Phase I study prior to major deliverable. • Successfully completed 3-month contract to fill in for SCDM on leave. • Initiated collaboration with project biostatistician on refining univariate edit checks. • Rapidly assimilated 2 unfamiliar EDC systems. • Used prior, self-taught SQL knowledge to test, write and edit error check specifications.

Durham, Nc

Data management of site and investigator intelligence within a matrix environment. Technical support for multiple clinical trial feasibility studies at a time. Create, customize EDC, site contact strategies in compliance with multinational regulatory agencies. Inform project leaders of key events and provide immediate updates via customized reports. End user training, issue resolution, data validation, upload data to DBMS with quality and timeliness. Participate in kick off meetings. • Developed and presented training within group and to Clinical Trial Specialists worldwide. • Participated on teams focused on enhancing tools. • Performed user acceptance testing for newly automated processes.

Repeatedly won confidence of diverse and highly-perceptive individuals, with little or no preparation or assistance. Personally requested numerous times to fill positions at magnet schools due to ability to quickly assess the situation and hit the ground running. Created consistency through observation and correct interpretation of context clues. Good-naturedly invested effort necessary to achieve goals as specified.

Durham, Nc

Ensure data quality for NIEHS epidemiology surveys - Test / validate forms, databases, EDC, logic checks; train data entry assistant. Provide input to Principal Investigator(s) and Study Manager on design of data collection forms and to resolve data quality questions. Design and build EDC forms and reports. • Used significant downtime to learn 3 DBMS's.• Requested to learn and evaluate Epi Info by studying the CDC website.• Reviewed data management tools and selected best tool for a client’s project.• Delivered project data with high quality, under budget and ahead of schedule.

Cary, Nc

DM lead, creating CRFs from protocol. Facilitate weekly meetings with Sponsor personnel. • Proven initiative & job knowledge merited unusual contract status to continue working for ClinTrials Research DM. • Succeeded in translating cross-functional team needs and concerns to create consensus.

Morrisville, Nc

Team Lead - mentored, explained project goals, motivated team, prepared and presented new project training. Desktop-published case report forms (CRF's), annotated CRF's, drafted database table layouts, wrote data flow SOPs, created validation checks. Led study using sponsor's Oracle-based software. Continued Sr CDC responsibilities on ongoing projects after promotion to supervisor.

Morrisville, Nc

Pioneered in-house EDC, customizing and testing DE screens for every clinical trial. Composed and implemented QC plan for company's first in-house Data Entry group. Created table layouts and SQL queries. Strong relationship with IT facilitated efficient collaboration on database setup for new projects and optimization of database features. Managed extremes in workload to include successfully negotiating for and overseeing 22 temporaries working 2 shifts and 3 regular employees. Excellent rapport with all functional groups. Simultaneously performed Sr CDC duties; led data cleaning for AIDS & contraception studies until database lock.• Developed and implemented quality and production monitoring methods• Member of team for Continuous Quality Improvement internal study; presented team’s findings at DIA meeting.

Raleigh-Durham, North Carolina Area

Participated in forms creation, testing SAS programs, data entry, CRFs and data reconciliation, auditing patient files. writing SAS programs to identify outliers, checking tables for Clinical Study Report (CSR). Coordinated between departments. Served on 100% ophthalmic review team. Shadowed veteran CRA on monitoring trips to Seattle and San Francisco.• Cross-trained in clinical monitoring, biostatistics and CSR editing.• Drafted and presented team's first CDC training.• Only CDC chosen to review data at sponsor's home office.

Bachelor'S Degree, Biology, General

Activities and Societies: Dai Nippon Butoku Kai Bushin Kan Dojo, Biology Club backpacking tripsW&M is a liberal arts university with area.

2.0 Continuing Education Units, Medical Terminology, 4.0