Manager Project

Name: Boggs, Heather

Position: Senior Lead Data Manager

Contact Details:

Address: *** ******** ***, ****, ** 27519

Phone: 919-***-**** (work cell phone), (919) 910-***-**** (personal cell phone)

Personal email: **************@*****.***

Summary

Over 10 years of experience in global CRO Clinical Data Management including 8 years in Lead role requiring direct, hands-on, collaborative work across all start up, production and close out Data Management tasks across all Phases (Phase I-IV) and various Clinical Drug Trial Protocol indications and Sponsors. Advanced graduate studies and experience in Clinical Psychology including course and lab instruction as well as non-human animal laboratory responsibilities. Experience conducting human behavioural research and providing counselling/behavioural treatments and services to patients in the community.

Education / Qualifications

Date Place of Education Qualifications

1996 UNC-Wilmington MA, Experimental Psychology (with accepted thesis)

1988 UNC-Chapel Hill BA, Psychology

Employment History

Employer/From – To Roles & Responsibilities

Quintiles / July 2008 – present Data Team Lead

• Provide experienced comprehensive skills as a part of the project corporate team to offer efficient, quality data management products that meet client needs.

• Provide leadership to the data management team (including Programming, clinical coding, data entry, forms control, data review) in the areas of project set-up through database QC audit and closeout.

• Create project-specific processing documents (including data validation guidelines) in accordance with Standard Operating Procedures and Project Scope of Work.

• Tests database system and programmed checks against expected outcomes.

• Perform and Lead data review activities and comprehensive QC including external data reconciliation, SAE Reconciliation, etc.

• Coordinate activities with client and other corporate team members (including biostatistics, clinical, project management, etc.), and third party data vendors/labs. Manage data management timelines, plus data management components of project budget.

• Manage database audit and other closeout activities.

PPD / August 2004 – June 2008 Clinical Data Manager I, Clinical Data Manager II

• Acted as a Lead Clinical Data Manager for one or more projects.

• Provided support to another Lead Clinical Data Manager for one or more projects.

• Liaised with clients and colleagues in other functional groups as required.

• Fulfilled all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation.

• Designated tasks appropriately within the team ensuring all work conducted was completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and the DVM.

• Represented Clinical Data Management at internal and external meetings and presentations.

Rho Inc. / July 2000 – July 2003 Clinical Data Associate/Lead Trainee/Lead

• Designed Case Report Forms in accordance with Sponsor preferences and the study protocol.

• Produced the Case Report Forms and distributed them to the different study sites.

• Compiled Data Management Plan & obtained approval from CDM Manager & Project Manager

• Annotated the Case Report Form (including Phase, Dataset and Variable).

• Programmed the Data Dictionaries for each separate dataset in SAS.

• Designed and created Data Entry Screens.

• Entered and tested Test Data (“Dummy Data”).

• Maintained and updated project documentation files with all necessary project specific documents.

• Coordinated and organized team resources in order to meet or exceed all deadlines.

• Wrote and tested Edit Checks (coordinating with study programmer).

• Set up all forms necessary for Data Entry (including tracking).

• Conducted inventory, copy and track of original CRFs received.

• Wrote Data Entry Guidelines and Pre-entry Review training notes and trained Data Entry personnel.

• Performed pre-entry CRF review in accordance with study guidelines.

• Identified, resolved, and updated data discrepancies in the clinical database.

• Identified necessary listings of data.

• Wrote manual queries (queries that did not generate automatically, for example, queries generated due to listings).

• Reviewed data listings for accuracy and consistency of data.

• Entered discrepancies into SAS discrepancy database as a result of DM and clinical data listing reviews.

• Resolved data entry discrepancies per self-evident corrections and query resolution.

• Generated Query Backlog and other reports as needed.

• Performed annotations to the case report form per self-evident corrections and query resolution.

• Provided daily metrics/updates to manager and/or Sponsor.

• Provided weekly updates to sponsor & Meeting with Sponsor (by phone or in person) as needed.

• Communicated, as needed, with project manager.

• Communicated, as needed, with site coordinators and/or monitors on query issues, unreceived CRF pages, etc.

• Provided various task-specific training to new hires and other team members.

• Performed QC review of the data and made appropriate corrections to database.

• Set status on discrepancies created during data validations.

• Performed DM closeout on resolved queries.

• Completed lock and freeze activities for finalization of database.

UNC-Greensboro / August 1996 – May 1998 Graduate Teaching and Research Assistant in PhD Clinical Psychology program

• Taught undergraduate Psychology courses.

• Conducted behavioural research.

• Provided counselling and psychological services to community patients.

UNC-Wilmington / August 1994 – July 1996 Graduate Teaching and Research Assistant in Masters of Experimental Psychology program

• Assisted with undergraduate Psychology courses

• Lead behavioural laboratory activities

• Conducted behavioural research.

• Maintained animal laboratory.

UNC-Chapel Hill/ June 1993 – July 1994 Research Assistant, Department of Psychiatry

• Assisted research coordinator in the field (several elementary school districts across North Carolina) with collecting and databasing research on school-aged childrens’ understanding of HIV/Aids.

Employment Law Research, Inc., Durham, NC / May 1989 – May 1993 Office Manager

• Provided all office management needs including accounting/payroll and administrative research in office of highly-respected law research attorneys affiliated with the Duke University School of Law.

Most recent Project Experience

Phase/

Date

Indication

Number

Countries Number Sites & Patients Description of Responsibilities and Tasks

Ia/July 2011-current Migraine 1 1 site, 48 patients Lead Data Manger responsible for all set up and all production tasks

I/April 2011 – current Asthma 1 4 sites, 48 patients Lead Data Manger responsible for all set up and all production tasks

Ib/Dec 2008 – Nov 2010 Osteoporosis 1 2 sites, 52 patients Lead Data Manager responsible for some set up, all production and majority of closeout/lock & freeze tasks

I (FIH)/Oct 2008 - current Advanced Solid Tumors 1 3 sites, 68 patients Lead Data Manager responsible for some set up, all production tasks, and all closeout/lock & freeze tasks

I/July 2008 – Oct 2011 Idiopathic Pulmonary Fibrosis (IPF) 1 2 sites, 98 patients Lead Data Manager responsible for all production and closeout/lock & freeze tasks

III /June 2007 – June 2008 Pulmonary Embolism & Deep Vein Thrombosis 20+ 100+ sites, 2000+ patients Lead Data Manager responsible for all set up tasks

III / December 2007 – June 2008 Pulmonary Embolism & Deep Vein Thrombosis 20+ 100+ sites, 2000+ patients Lead Data Manager responsible for all set up tasks

II / December 2006 – June 2008 Metastasized Prostate Cancer 10+ 20+ sites, 200+ patients Lead Data Manager responsible for all production and closeout/lock & freeze tasks

III / October 2004 – June 2006 Influenza Vaccine 20+ 100+ sites, 2000+ patients Lead Data Manager responsible for all set up, production and closeout/lock & freeze tasks

II/III / July 2006 – May 2008 Influenza Vaccine 10+ 20+ sites, 200+ patients Lead Data Manager responsible for all set up, production and closeout/lock & freeze tasks

III / August 2004 – October 2004 ADHD 10+ 20+ sites, 200+ patients Assisted Lead Data Manager with various production tasks

IIIb / August 2004 – October 2004 ADHD 10+ 20+ sites, 200+ patients Assisted Lead Data Manager with various production tasks

III / December 2005 – July 2007 Prophylaxis of RSV in High-Risk Children 20+ 100+ sites, 2000+ patients Assisted Lead Data Manager with various production tasks

Systems Experience/IT Skills

PC Skills

Windows

MS Word

Excel

Power Point

Lotus Notes

Word Perfect

Access

Medidata Rave (EDC) Version 5.6.3.86

Oracle Clinical Version 4.01, 4.03 and 4.05

Oracle Clinical Remote Data Capture (OC-RDC) Version 4.5.3

SAS Version 6

Other Relevant Details

Management Training Seminar series completed while with Rho Inc.

Contact this candidate