Data Entry Associate
Resume:
KIM L. BROWN
Laurel, DE *****
*******@*****.***
DATABASE EXPERIENCE
Experience in EPX, EXPERT, Study Works, InForm, MIRA, PIER, Sparc, Medidata - RAVE, EDC/RDC, CRF Express, Oracle Clinical, Clintrial, CDSSS, Dilpomat, Velos, Microsoft Access, SAS, S3, Datafax, Watson, MedDRA, WhoDrug, ICD-9 coding.
THERAPEUTIC EXPERIENCE
Pulmonology
oAcute Exacerbation of Chronic Bronchitis
Neurology
oPainful Diabetic Peripheral Neuropathy
Oncology
oCellar Immunotherapies
oOxygenation in Post-operative Patients with High Grade Glioma (HGG)
oSecondary Acute Myeloid Leukemia (AML)
Pediatrics/Neonatology
oAcute Respiratory Distress Syndrome in Newborns
Rheumatology
oOsteoarthritis
Female Health
oHormone Replacement Therapy
oBirth Control
Gastroenterology
oGERD
Urology
oNormal Renal Function or Mild or Moderate Renal Impairment
Infectious Disease
oOtitis Externa
oClostridium Difficile Infection
Endocrinology/Metabolic Disorder
oDiabetes Mellitus
Other
oAcute Low Back Pain
oAcute Hereditary Angioedema (HAE) Attacks
PROFESSIONAL EXPERIENCE
ERT, Philadelphia, PA. 4/2017 – 09/2021
Clinical Data Manager
Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited to; data collection, data cleaning, data delivery, data reconciliation, database lock and Data Management activity timelines
Define the Data Management Plan (DMP); Collaborate with Sponsors to define study requirements, determine standard edit checks necessary to ensure clean data and define new edit checks when standard checks are insufficient. Develop Query Guidelines and SEC rules to minimize the query burden on sites while ensuring accurate demography and visit information is obtained. Collaborate with internal teams on study setup requirements such as demographic collection and visit schedule requirements. Communicate contents and commitments in the DMP to the internal CDM teams. Complete data management related pages in EXPERT.
Lead the development, review, and finalization of data transfer requirements. Provide or customize ERT standard file specifications, review and/or consult with Sponsor on Sponsor-defined specifications, and coordinate finalization and approval of file specifications between Sponsors and SAS Programmers. Maintain approved file specifications. Perform any required validation of file formats or data content. Submit SAS programming requests for data file creation or edit check creation. Generate sample data from live study data. Provide sample data and the Data Transfer Agreement to the Sponsor teams. Maintain the signed Data Transfer Agreement. Manage database lock activities and timelines with the Sponsor to ensure data integrity and deliverable timelines are met. Serve as primary point of contact for query escalation. Routinely review and resolve escalated queries. Provide consolidated escalated query listings to Sponsor teams. Resolve Sponsor or Site issues escalated through Customer Care.
Create and review Data Archives for Sponsors and Sites
Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times.
Identify out of scope requests and elevate these requests to the Project Manager so that they can be properly billed through the Change Order process.
Ensure Data Management Files are up-to-date and comprehensive including, but not limited to, Data Management Plans, Files Specifications, Data Transfer Agreements, Data Correction Forms and Requests, client emails, etc.
Conduct routine status meetings with Sponsor/CRO and internal teams. Provide agenda and meeting minutes to all attendees.
Process at least one routine data run per assigned study per quarter and perform all sample, complete and final data sends.
Assist in the preparation of monthly reporting by providing metrics as required.
Communicate project status clearly with Sponsors and Project Management.
Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation.
Lead in CAPA issues related to study-specific data management activities.
University of Pennsylvania, Philadelphia, PA. 9/2016 – 1/2017
Clinical Data Manager
Responsible for all tasks associated with study data management necessary for DSMB meetings/report, IND reports, monthly reports, and interim data reporting/ database locks, as well as ad hoc reports
Independently create CRFs in electronic database systems to collect data from all clinical trials
Continually evaluate the CRF’s for required modification due to the dynamic nature of the research
Amend CRFs due to protocol amendments/changes in study endpoints
Assist in the development and review of study-specific data management documents, including Data Management Plans and Case Report Form Completion Guidelines, as well as sponsor data management standard operating procedures
Developing and conduct Investigator/Study Team training on the Clinical Database, CRFs, and data entry requirements
Provide input into study and project level data analysis plans
Participate in the preparation and presentation of study data/reports
Facilitate data cleaning activities including data review and query generation for assigned protocols
Produce and provide metrics on data entry/processing to the Project Manager
Assist in implementing process changes and system improvements
Covance Clinical Development Services, Conshohocken, PA/USA 10/2015 – 3/2016
Senior Clinical Data Coordinator (Real Staffing)
Serve as a member of the project team with primary responsibility for clinical data review
Query generation, resolution and reconciliation activities to support the delivery of clinical
data according to client quality and integrity specifications, and project timelines and productivity targets.
Development of the project Data Management Plan, including the creation of data acquisition
conventions and data review guidelines, diagnostics specification; and set-up of the data management systems according to project requirements.
Serve as the technical data management leader on small to moderate project with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, project timelines and budgets.
ICON Medical Imaging, Warrington, PA. 8/2012 – 10/2015
Project Data Lead
Participate as the Data Management representative on study teams
Represent Data Management at Kick-off, Charter and SRS team meetings
Review and provide input into Charter and SRS during creation
Work with Systems Development and database structure and code lists
Work with Sponsor and/or CRO to develop Data Delivery Specifications (DDS) Inbound and Outbound
Work with DBA, SAS programmers and System Development to coordinate and code delivery in accordance with specification
Work with DAB,SAS programmers and System Validation team to ensure test data is acceptable and meet requirements of test plan
Coordinate loading of reconciliation data into PIER for Clinical Operations
Create project specific edit check document and work with DBA’s to create, test and implement
Work with DBA to generate client reports, graphs or light analysis to client requirements
Review and approval of deliveries to Sponsor/CRO
Quality review of incoming clinical data
Coordination of loading of clinical data
Assist in maintaining database documentation
Implement quality control procedures
Investigate and analyze discrepancies in data and report to DBA
ViroPharma Incorporated, Exton, PA. 12/2011- 8/2012
Sr. Clinical Data Associate (Aerotek)
Follows established GCP procedures and practices for implementing and maintaining processes to assure departmental goals are met.
Reviews clinical trial data utilizing departmental SOPs, Guidance documents and Study Specific guidelines.
Participates in UAT of developmental databases
Assumes data management study lead role for assigned studies
Creates study start up documents
Authors and reviews data management process documents and SOPs
Oversees daily assignments for data reviewers
Participates in Monitor training and Investigator’s meetings
Leads data management driven study team meetings
Communicate study specific issues to study manager or project team
Performs data review
Performs SAE and Lab data reconciliation
Participates in database lock and study closeout activities
Attends and participates in departmental and interdepartmental meetings
Other duties as assigned
INC Research, Inc., King of Prussia, PA. 10/2007 – 2/2011
Clinical Data Associate II
Developed all the study-specific documents which meet sponsor specifications.
Created test data for user testing of database screens.
Created electronic edit checks.
Performed User Testing and analysis of Data Entry Screens and accurately records problems.
Participated in the execution of electronic edit checks test plans.
Performs database analysis and routine quality control checks following specified guidelines.
Diagnoses and identifies root cause of problems in discrepancy management process and suggest solutions to Lead Data Manager when assisting on other projects.
Performs medical data encoding as specified in study-specific Coding Plans and the study protocol.
Participates in internal CDM audits and the development and documentation of action plans.
Performs Clinical Data Associate I duties as required.
Lead Data Manager on Oncology study in EDC/RDC database.
Participated in Bid Defense for Oncology study.
Participated in Quick Start Camp for Oncology study.
Conducted training for EDC/RDC for sponsor, INC team members, study coordinators and investigators.
Participates in sponsor teleconferences.
Mentors and trains new or less experienced team members.
Generates manual or programmed data management status reports.
Assist in data validation for study utilizing the RAVE database
MDS Pharma Services, King of Prussia, PA. 12/2006-10/2007
Senior Database Coordinator/Clinical Data Reviewer (ClinForce)
Validate all CRF’s from a clinical perspective to assure medical accuracy and consistency; resolving,
adding to, or validating queries as needed.
Work with Data Coordinators to review QC reports, in an effort to resolve queries promptly to ensure
clinical and data quality
Assist CRA’s by participating with in-house data monitoring to ensure study sites effectiveness and
responsiveness to queries.
Collaborate with Data Coordinators, CRA’s and Project Managers in preparation for database lock; to review batch edit check output, and communicate with Study Coordinator’s in an effort to resolve queries promptly.
Participate in CRF design, edit check spec development and validation guidelines creation.
Participate in Project Team, Client and Investigator Meetings
Interface with other departments as a clinical resource to clarify and resolve clinical issues.
Work with the coding and safety departments to address all coding and safety issues.
Review AE and Con Med listings for accuracy and consistency of data.
Glaxo Smith Kline, Philadelphia, PA. 5/2005-11/2006
Clinical Data Manager (ClinForce)
Serve as department representative to cross-functional clinical project teams for phase l studies
Recommend and monitor timeliness communicate project status for assigned work
Provide data quality metrics and feedback to clinical monitors and study site personnel
Execute database management programs, perform data maintenance and validation procedures
Accountable for authorized databases for reporting
Maintain accurate project documentation
Generate data outputs for clinical decision-making criteria and/or inclusion in clinical study reports
Interact with external groups, e.g., investigator site personnel, regional monitors, contract research organization (CRO) and external data supplier staff, for project plan execution and data query resolution
Develop, implement and maintain clinical trials processing and reporting databases to established standards with minimal guidance
Demonstrate working knowledge of and provide technical expertise for data management systems, e.g., electronic data capture, clinical trials databases, SAS, SQL and other software applications
Develop and maintain data entry and/or electronic data capture applications with minimal guidance
Assist in training of internal staff and external data vendors and contractors
Contribute to investigator meetings and study site visits
Review draft CRFs/protocols and approve final drafts
Develop pre-entry review guidelines
Write validation specifications
Create database specifications for contracted studies, laboratory and other electronically transmitted data and ensure that database structure and data quality conform to project standards and all the clinical data are loaded appropriately into the reporting database Coordinate CRO and external data supplier activities
Participate in monitoring/auditing of CRO and external data supplier sites, as required
Participate in implementation of new technologies. Contribute to data management process improvements
PharmaNet, Inc., Blue Bell, PA. 12/2004-4/2005
Data Analyst – Clinical Data Management – (M L P/Global Employment Solutions)
Clinical data coordination and review of a phase III study
Review data for discrepancies
Query generation and resolution
Lab reconciliation
Sanofi-Aventis, Malvern, PA. 3/2004-11/2004
Clinical Data Coordinator – Clinical Data Management – (Main Line Personnel)
Clinical data coordination and review of a phase III study
Review data for discrepancies and edit checks
Query generation and resolution
Participation in CRA Training
Assistance in development of review guidelines
Discovery Laboratories, Doylestown, PA. 8/2003-2/2004
Clinical Data Reviewer – Clinical Data Management - (Main Line Personnel)
Full data review first and second pass of a phase III study preparing for FDA submission.
Query generation and resolution.
CRF adjudication and ballot verification.
QC of multiple databases.
Trainer of DCF application.
Creator and administrator of adjudication tracking system.
Covance, Radnor, PA. 10/2002-2/2003
Clinical Data Coordinator
Kidney Transplant Study for Wyeth Pharmaceuticals.
Provided in-house departmental training.
Trained Assistant CDC and CDCs in project specific guidelines and instructions.
Created and validated of quality checks.
Provided data as needed to complete Key Result Indicators.
Developed and validated audits.
Created CRF/DENS to database.
Ensured all QC Checks/frequencies are completed and data is correct.
Checked electronic data transmissions against source data.
Updated database with information found in quality checks, audits, and from DCFs.
Imported and exported data between data systems.
Lab reconciliation.
Assisted project lead as liaison among pharmaceutical manufacturers, CROs, project teams and departments.
Resolved queries in the database.
Assisted in the development of Data Management Plan and Data Entry Guidelines.
Covance, Radnor, PA. 3/2001-10/2002
Assistant Clinical Data Coordinator
Assist with quality control audits and research.
Assist in study start up procedures.
Participate in teleconferences and project team meetings.
Create memos, meeting minutes and agenda’s.
Run and distribute weekly status report to client and team members.
Assist in database lock.
Covance, Radnor, PA. 2/2000-3/2001
Data Analyst
Check electronic data transfer against source data.
Prepare CRF’s for keying and or scanning.
Perform CRF review for inconsistencies of data fields.
Return erroneous CRF’s to CDC.
Maintain CRF tracking.
Create and maintain project specific files.
Wyeth Pharmaceuticals, St. Davids, PA.
Adverse Event Specialist - Safety – (Kelly) 9/1999 – 2/2000
Medical Data Assistant 8/1998 – 9/1999
Responsible for ADE, labs, medical history, narrative coding utilizing MEDRA, COSTART and WHO.
Setting up electronic follow-up letter schedules for physicians and consumers.
Electronic distribution of 3500A and CIOMS to affiliates and or business partners worldwide.
SAE reconciliation.
Enter spontaneous and literature adverse drug experiences (ADE’s) reported worldwide for US
Track reports to assure timely submission to the FDA.
Prepare periodic reports for submission to the FDA.
Coordinate MDA receipts and distribution of follow-up information for reports.
Organize and maintain ADE files assigned products.
Coordinate MDA portion of testing and validation of computer enhancements.
Provides routine computer summary reports and other non-routine reports to Drug Information, Legal, Medical Monitors, etc.
Hospital OF The University OF Pennsylvania, Philadelphia, PA.
Scheduling Coordinator for Gastroenterology 4/1997 - 3/1998
Schedule patients doctor appointments.
Coordinate appointments with various departments in hospital.
Coordinate transportation from different locations in hospital.
Call in prescriptions to hospital as well as local pharmacies.
Collect co-pays and administer receipts.
Data Entry Operator CPUP 3/1995 – 4/1997
Enter codes and modify patient appointments for billing.
Enter codes and modify surgical procedures for billing.
Comcast Cable Company, Philadelphia, PA.
HRIS Human Resources Information Systems Specialist 6/1991– 9/1994
EDUCATION
Hampton University, Hampton VA Computer Science
TRAINING
SAE Training CRF design
Study start - up CRF Tracking Trainer
ICD9 Coding Medical Terminology
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