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.
• 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.
• 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.
• 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..

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.
• 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.

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.
• 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)..
• 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