Brenda Harrison Email and Phone Number
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Expert in the field of management of clinical trial documentation (Trial Master Files) for domestic and global studies, including sponsor and vendor-managed studies. Supervise and manage staff responsible for collecting, importing and filing study documents into physical and electronic trial master files. Ensure sponsor TMF documentation is complete, accurate and audit ready.
Worldwide Clinical Trials
View- Website:
- worldwide.com
- Employees:
- 1625
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Global Director, Central Records And Document ManagementWorldwide Clinical Trials Jan 2014 - PresentMorrisville, NcResponsible for ensuring all project related study/trial ED are processed, maintained, archived and transferred per procedures and working practices. Oversees and ensures the adequacy and security of the regional central facilities. Oversee the management of the eTMF, ensuring alignment of DIA reference mode file structure, classification and nomenclature to provide ongoing visibility of study documents to project teams, sponsors, regulatory, medical monitors, drug safety, data management, etc.
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Clinical Records ManagerUnited Therapeutics Corporation Oct 2010 - 2014Rtp, Nc -
Manager, Qa Documentation/CompliancePfizer 2009 - 2010Sanford, NcManaged daily activities of four exempt / non-exempt QA RM/Documentation staff and contract/temporary employees responsible for document change management and control of the electronic document management system, document control center, development technical report program, off-site records storage, records retention scheduling, laboratory notebooks program, etc.Managed and operated the GMP quality system for records management in support of the development and release of clinical trial material.Primary contact for support of internal/external audits and inspections. -
Manager, Qa Operation DocumentationWyeth Pharmaceutical Co., Ltd. 2002 - 2009Sanford, NcManaged daily activities of four exempt / non-exempt QA RM/Documentation staff and contract/temporary employees responsible for document change management and control of the electronic document management system, document control center, development technical report program, off-site records storage, records retention scheduling, laboratory notebooks program, etc.Managed and operated the GMP quality system for records management in support of the development and release of clinical trial material.Primary contact for support of internal/external audits and inspections. -
Manager, Records Management, Quality ComplianceTriangle Pharmaceuticals 1998 - 2002Durham, NcEstablished and maintained data integrity of critical Research & Development, Regulatory and Medical documentation in DOCS Open document management system. Standardized document types, developed workflow techniques, wrote procedures to prepare documents for electronic submission. Familiarity with 21CFRPart 11.GLP Archivist: Oversaw the activities of corporate archives including laboratory, manufacturing, and clinical document collections in addition to research laboratory notebooks and internal reports. Ensured archival documents were maintained according to GLP regulations. Developed retention schedules in accordance with regulatory, corporate and departmental needs. Performed compliance audit functions according to valid retention guidelines. Analyzed media requirements and alternative technologies for records maintenance and access. Developed and maintained regulations citation database. Managed off-site storage of records/documentation. Set-up and maintained central document control room. Performed strategic online searches (literature,patent, etc.) of data. Established and maintained corporate library. Supervised and trained contract employees.
Brenda Harrison Skills
Brenda Harrison Education Details
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Nc Wesleyan CollegeAdministration -
Nc Wesleyan CollegeBusiness Administration
Frequently Asked Questions about Brenda Harrison
What company does Brenda Harrison work for?
Brenda Harrison works for Worldwide Clinical Trials
What is Brenda Harrison's role at the current company?
Brenda Harrison's current role is Global Director, Central Records and Document Management at Worldwide Clinical Trials.
What is Brenda Harrison's email address?
Brenda Harrison's email address is bh****@****her.com
What is Brenda Harrison's direct phone number?
Brenda Harrison's direct phone number is +191946*****
What schools did Brenda Harrison attend?
Brenda Harrison attended Nc Wesleyan College, Nc Wesleyan College.
What are some of Brenda Harrison's interests?
Brenda Harrison has interest in Social Services, Children, Economic Empowerment, Civil Rights And Social Action, Politics, Education, Science And Technology, Health.
What skills is Brenda Harrison known for?
Brenda Harrison has skills like Quality Assurance, Sop, Gmp, Fda, Pharmaceutical Industry, Software Documentation, Glp, Clinical Trials, 21 Cfr Part 11, Document Management, Quality System, Quality Auditing.
Who are Brenda Harrison's colleagues?
Brenda Harrison's colleagues are Milos Stojic, Harshita Talasila, Shirley Schroeder, Milena Ojdanic, Tamara Stanic, Jacqueline Wyatt, Liudmyla Sydorova.
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