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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Professional Summary
I am a Data Management professional with 20+ years of global Contract Research Organization experience consistently managing multiple projects and teams, meeting or exceeding deadlines, while training and mentoring within a diverse matrix environment. I have spearheaded training, system integration and validation initiatives, as well as managed strategic partnership alliances. I have a proactive management style based on open communication and setting realistic expectations.
Skills
  • Accomplished managing multiple projects/ sites/vendors across US, Europe, Asia, and India
  • Oversee direct reports
  • Seasoned Data Manager with experience in Oncology, Cardiovascular, Alzheimer's, Pain, CNS including imaging endpoints
  • Developed and implemented training programs for internal and external customers

  • Proficient using Microsoft Office Word, Excel, Project, Outlook, Lync, SharePoint, Cisco IP Communicator, WebEx
  • Experienced using the following database platforms -Oracle Clinical, Oracle Clinical RDC, Datafax, eDM, CTMS (ACR developed database), Adaptive Clinical (based on OpenClinica), Medidata RAVE, Clinical Conductor CTMS
  • Basic knowledge of SQL and SAS.
Work History
Senior Project Data Manager, 02/2016 to Current
KpmgMontvale, NJ,
  • Provides line management responsibility as well as acting as Project Leader on partnership Data Management studies (primary customer contact, direct liaison with Finance and Contract departments regarding invoices and change orders). 
  • Acts as Functional Lead for Data Management on full service contracts including: primary contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups on 'full service' contracts; liaison with Finance and Contracts groups via the Project Leader (e.g., concerning invoicing, contract changes - change orders/change requests).
  • Ensures launch, delivery and completion of all Data Management deliverables according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
Clinical Informatics Specialist (Global Data Manager), 03/2015 to 02/2016
Crown Castle Usa IncColumbia, MD,
  • Managed Data Management timelines and deliverables including Medidata RAVE Database setup, validation, transfers, and all other operational aspects of clinical trials in compliance with Good Clinical Practice (GCP) regulations.
  • Adhered to financial/administrative processes related to trial budget/timeline management and accurate estimation of resource needs.
  • Experienced communicating with departments outside of Data Management.
Director, Data Management, 05/2010 to 09/2014
Fred Hutchinson Cancer Research CenterMultiple Locations, WA,
  • Provided strategic oversight of all Data Management activities and deliverables within an Imaging Contract Research Organization (iCRO) centric research division.
  • Developed standard operations procedures, work instructions, and designed system requirements for Clinical Data Management System (CDMS) acquisitions.
  • Supervised managers and acted as system owner of multiple Clinical Data Management Systems.
Manager, Data Management, 01/2008 to 05/2010
OhlCompton, CA,
  • Experienced in project/program management oversight for all data management activities (Data Management  Plan, Data Validation Specifications, Data Transfer Specifications. Serious Adverse Event Reconciliation Plan, Protocol Deviation Reconciliation Plan). 
  • Seasoned in presenting at capabilities, bid defense, and investigator meetings. 
  • Managed direct reports (resourcing, mentoring, training, career development, issue resolution, evaluations of staff/financial compensation, invoicing, revenue recognition, adherence to Good Clinical Practices (GCP) standards, standard operation procedures, and working guidelines).​
Manager, Data Coordinators, 03/2006 to 2008
Banner HealthFort Collins, CO,
  • Worked closely with Biometrics and Clinical Management to ensure studies were resourced appropriately and deliverables were met.
  • Interviewed data management personnel, conducted annual reviews, and initiated training programs for new employees. 
  • Provided oversight for database set-up and all data management processes in order to achieve database lock. 
Data Coordinator II, 10/2004 to 03/2006
Fedex Cross BorderLinthicum Heights, MD,
  • Conducted interviews and trained Data Coordinators.
  • Developed a training program for new employees.
  • Communicated directly with sites. 
Clinical Data Manager (part-time), 01/1994 to 10/2004
1-800-Flowers.Com, Inc.Hebron, OH,
  • Managed databases.
  • Reviewed client data structures and specifications.
  • Created/implemented edit checks. 
Quality Assurance Coordinator, 09/1991 to 10/1993
Research Data CorporationCity, STATE,
  • Created Case Report Forms (CRFs) and databases. 
  • Reviewed client data structures and specifications.
  • Validated Computer Aided New Drug Application (CANDA) systems and trained client/Food and Drug Administration (FDA) on its use. 
Clinical Research Assistant, 07/1990 to 09/1991
Research Data CorporationCity, STATE,
  • Validated client databases.
  • Supported Clinical Research Associates in validation of Computer Aided New Drug Application (CANDA) systems.
  • Conducted review of trial master files (TMFs).
Quality Control Assistant, 07/1986 to 07/1990
Cardio Data SystemsCity, STATE,
  • Reviewed analysts' 24-hour ECG reports for accuracy.
  • Coordinated site set-up and client training in Europe and US.
  • Developed training curriculum for new personnel in the UK and US.
Senior Analyst, 09/1982 to 07/1986
Cardio Data SystemsCity, STATE,
  • Assumed supervisor responsibilities when necessary.
  • Analyzed 24-hour ECG recording.
  • Reviewed reports for accuracy prior to sending to client.

Education
Bachelor of Arts: Biology, Expected in 1981
Rutgers University - Camden, NJ
GPA:

RCT Certified: , Expected in 1987
National Board of Cardiovascular Testing - ,
GPA:
Top 5% in October 1987 exam

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Resume Overview

School Attended

  • Rutgers University
  • National Board of Cardiovascular Testing

Job Titles Held:

  • Senior Project Data Manager
  • Clinical Informatics Specialist (Global Data Manager)
  • Director, Data Management
  • Manager, Data Management
  • Manager, Data Coordinators
  • Data Coordinator II
  • Clinical Data Manager (part-time)
  • Quality Assurance Coordinator
  • Clinical Research Assistant
  • Quality Control Assistant
  • Senior Analyst

Degrees

  • Bachelor of Arts
  • RCT Certified

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