Sandra B. Email and Phone Number
Sandra B. work email
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Sandra B. personal email
Over 15 years’ proven ability to apply: analytical and problem-solving skills; clinical and scientific knowledge; extensive experience with EDC and clinical databases. Specializing in cross-functional communication to automate and streamline processes from protocol to abstract. An effective communicator; delivered presentation at a DIA Workshop on Upstream Quality Management.THERAPEUTIC AREA EXPERIENCEPhase I-II Oncology: Leukemia/Lymphoma; Solid Tumor – RECIST criteriaPhase III-IV: Cardiovascular diseases, Dermatology, Endocrinology, Gastroenterology, Immunology/ Rheumatology, Neurology, Oncology, Ophthalmology, Psychiatry/Psychology, Pulmonary diseases.Non-interventional: NHS Cardiology, DMD, LGMD; chart reviews; epidemiology surveys
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Sr Clinical Data Team LeadPpd Nov 2018 - PresentUnited States -
Clinical Data LeadDocs Oct 2017 - Nov 2018RemoteProtocol 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. -
Cdm Contractor - Pra Health ServicesZachary Piper Solutions Apr 2017 - Jul 2017Raleigh, North CarolinaProvide immediate results in preparing Phase IIIa oncology megatrial data for interim analysis. -
Clinical Data Manager (Contract)University Of North Carolina At Chapel Hill School Of Medicine Jun 2016 - Mar 2017Aerotek Contractor To Lineberger Comprehensive Cancer CenterManage 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. -
Contract Senior Clinical Data ManagerClinipace Worldwide Apr 2015 - Jul 2015Morrisville, North CarolinaDM 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. -
Site Intelligence AnalystParexel Feb 2010 - Sep 2014Durham, NcData 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. -
Substitute TeacherWake County Public School System Nov 2000 - Feb 2010Repeatedly 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. -
Data Manager I (Contract)Clinforce Contractor To Social & Scientific Systems Nov 2007 - Mar 2009Durham, NcEnsure 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.
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Clinical Data ContractorSyneos Health (Previously Inc Research/Inventiv Health) Mar 1994 - Oct 1994Cary, NcDM 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. -
Senior Clinical Data CoordinatorSyneos Health (Previously Inc Research/Inventiv Health) Nov 1991 - Mar 1994Morrisville, NcTeam 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.
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Data Entry SupervisorSyneos Health (Previously Inc Research/Inventiv Health) Oct 1992 - Dec 1993Morrisville, NcPioneered 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.
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Clinical Data CoordinatorSyneos Health (Previously Inc Research/Inventiv Health) Jun 1989 - Nov 1991Raleigh-Durham, North Carolina AreaParticipated 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.
Sandra B. Skills
Sandra B. Education Details
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Biology, General
Frequently Asked Questions about Sandra B.
What company does Sandra B. work for?
Sandra B. works for Ppd
What is Sandra B.'s role at the current company?
Sandra B.'s current role is Sr Clinical Data Team Lead.
What is Sandra B.'s email address?
Sandra B.'s email address is sb****@****tek.com
What schools did Sandra B. attend?
Sandra B. attended William & Mary, Durham Technical Community College.
What are some of Sandra B.'s interests?
Sandra B. has interest in Riding My Suzuki Gsx R 750 Sportbike, Children, Obtaining My Ccdm Credentials, Civil Rights And Social Action, Animal Welfare.
What skills is Sandra B. known for?
Sandra B. has skills like Clinical Research, Clinical Trials, Protocol, Public Speaking, Sop, Edc, Cro, Leadership, Microsoft Office, Training, Problem Analysis, Relational Databases.
Who are Sandra B.'s colleagues?
Sandra B.'s colleagues are Monika Ambardar, Molly Butler, Wong Juliana, Natalie Dunlop, Olha Belotskaya, Mayil Rajendran, Heather Rapp.
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