Project Manager Quality Assurance
Resume:
ALEXANDRA KREIFUS
Livingston, New Jersey *****
Livingston, NJ 07039
Phone: 973-***-**** E-mail
********@*****.***
SUMMARY OF QUALIFICATIONS
. Strong knowledge of drug development process, site monitoring, GCP and
FDA regulations.
. Proven ability to manage multiple projects over different operating
areas, prioritize and deliver timely, high quality results.
. Strong background in computer technology, data management and data
analysis, with extensive expertise in clinical documentation
management and clinical quality assurance.
. Highly motivated, detail oriented, with strong interpersonal and
exceptional ethics skills.
. Ready and willing to accommodate frequent local, domestic or
international business travel.
PROFESSIONAL EXPERIENCE
SANOFI AVENTIS, Bridgewater, NJ Feb 2008 - Jan 2010
CRA/Project Manager (contract position)
Clinical Trial Document Management, Clinical Operations
. Reviewed current Trial Master File (TMF) set-up of and filing procedures
of all study documents collected during the start-up, implementation,
management and close-out of clinical trials.
. Provided management with scalable solution for standardized and timely
TMF filing across all studies in compliance with applicable work
instructions, SOPs and ICH GCP guidelines.
. Reviewed development-approval workflow of essential clinical trial
documents (Protocol, CSR, ICF, CRF etc.) and identified major
opportunities for process improvement in documents collection.
. Created presentation and training material on Clinical Trial regulatory
documentation management.
. Participated in the development and review of SOPs, guidelines and work
instructions.
. Worked closely with the Clinical Project Team to support various aspects
of a Clinical Trial.
Drug Safety/Periodic Adverse Experience Reporting
. Analyzed existing Periodic Adverse Experience Reporting (PADER) process
for Medical Affairs.
. Acted as liaison between US Pharmacovigilance Drug Safety's Submissions
group and development team to facilitate automation and process
improvement of FDA reporting.
. Collaborated with Regulatory Affairs department to gain consensus on
PADER electronic review and FDA submission schedule and to ensure
compliance with 21 CFR 314.80, 600.80 etc.
. Designed electronic scheduling and notification algorithm for PADER
system, enabling automated report preparation from workflow initiation
through review and approval process.
. Planed, developed and executed full cycle of Quality Assurance activities
for PADER process implementation in accordance with company SOPs and
industry standards.
. Created PADER's process documentation and conducted training for US
Pharmacovigilance group.
Drug Safety/Signal Detection Reporting
. Performed business analysis of Adverse Events and Signal Detection
reporting process to FDA.
. Developed and authored requirements for process automation: Safety
Documents system.
Safety Documents system provides centralized electronic document
repository for drug safety monitoring, document review, automated
notification, workflow, electronic signature approval process and
electronic document trail for Signal Detection Schedule, Reports and
Forms.
. Developed and executed full life cycle of Quality Assurance activities
for new Safety Documents system in compliance with 21 CFR Part 11,
Electronic Records; Electronic Signatures regulations.
. Created training material and conducted group and one-on-one training for
Drug Safety team.
GREEN MOUNTAIN CONSULTING INC., Cranbury, NJ Aug 2005 -Feb 2008
Clinical Research Associate
. Conducted site evaluation, site initiation, routine and close-out
monitoring visits to ensure compliance with the protocol. Finalized IRB
documentation.
. Documented monitoring activities in monitoring reports and follow-up
letters.
. Performed source data verification and investigational product
accountability, reviewed site study file for completeness.
. Performed SDV - both paper and electronic; hands-on experience with
InForm, eDiary, TrialManager, IVRS.
. Performed site monitoring of Phase III, IIIb and IV clinical Trials in
therapeutic areas of gastroenterology, immunology and dermatology.
. Ensured site compliance with study protocols, ICH GCP and applicable
regulations.
. Established professional relationship with investigator's team to
facilitate on-going studies and to identify potential sites for upcoming
protocols.
PRUDENTIAL FINANCIAL, Livingston, NJ 1999 - 2005
Project Manager/Quality Assurance
. Functioned as a point of contact between User group and development team.
Thoroughly reviewed business requirements, scheduled walkthrough and
helped identify and resolve critical issues.
. Planned, developed and executed full life cycle of Quality Assurance
activities for system releases.
. Utilizing programming background, designed, developed and implemented QA
reporting system.
. Conceptualized, recommended and led efforts to reduce testing resources
by 20% on the project.
. Conducted user training, assisted in planning and implementing of user
acceptance testing.
Project Manager/Information Technology
. Led team of developers supporting Global Life Insurance systems ensuring
high quality projects were delivered on time and within budget.
. Managed system migrations, database upgrades, data conversion and
reconciliation.
. Partnered with team of actuaries to redesign Actuarial Reporting system.
Managed seamless conversion of actuarial data base and reporting
functionality to a new platform. Retiring actuarial legacy system
resulted in major business process improvement and 30% cost reduction.
. Planned and coordinated companywide initiatives including Y2K, Disaster
Recovery and Continuation, Information Security Gramm Leach Bliley
Privacy Act etc.
. Responsible for procurement of required hardware, software and contracted
services.
DANIRA CONSULTING, INC, New York, NY 1997 - 1999
Project Manager, Consultant
. Recognized for successfully leading cross-functional team through the
full project life cycle.
. Performed data analysis, reconciliation and conversion for Data
Warehousing project.
. Designed and developed Resource Utilization Report in MS Access for the
IT department.
ACCENTURE (formerly ANDERSEN CONSULTING), Florham Park, NJ 1987 - 1997
Senior Specialist
. Managed Group Insurance Data Management and Reporting System.
. Wrote SQL queries to extract and analyze data. Performed data validation
and issue resolution, provided periodic and ad hoc reporting to senior
management.
. Managed day-to-day operations, technical troubleshooting and business
user support.
EDUCATION
Clinical Research Associate Certification, Institute of Pharmaceutical
Technology, Hackensack, NJ
M.S. in Engineering, St. Petersburg State Polytechnical University, Russia.
Additional skills
Technical Skills: MS Office (Word, Excel, Access, PowerPoint), Visio, SAS,
Documentum, SharePoint, Siebel, SQL Server, Sybase, Business Object, Visual
Basic, Lotus Notes, PVCS Tracker.
Languages: fluent in Russian, Ukrainian, knowledge of French, Czech, and
Polish.
Contact this candidate