Clinical Data Professional

Gary McLean

*** ********** ***, ********** **, **571 / C: 919-***-****, H: 919-***-**** / ********@***.***

Objective

To transition into a position as Clinical Data Manager, in a well established and leading Clinical Research

Organization and Pharmaceutical company, in order to utilize my data, research, and analytical

background.

Profile

Over (9 Years) of Data Management experience.

Extensive knowledge in Data Analysis and Design.

More than 5 years experience in Electronic Data Capture (EDC)

Performed UAT, Query Management, Listing Review, CRF Design, and the building of databases

in multiple (EDC) platforms, which include: Medidata Rave, Oracle Clinical(OC), Remote Data

Capture (RDC), Inform and Open Clinica.

An impeccable attention to detail.

Proven ability to relate to client, staff, and management in order to deliver an excellent product.

Focused on completing individual goals, that ultimately results in completed team goals.

Prosper in timeline driven settings, that allows me to focus, while adjusting to my environment

Remain approachable in a tense atmosphere, that allows me to be open to change in my duties

Ability to communicate and adjust to all personnel and management in a priority based setting.

Summary of Skills

Communication Technical Design User Acceptance CRF Design

Testing

Team Work Business objects Database Build Edit Specification

Writing

Focus on Quality Perform Data Analysis Project Management Discrepancy Tracking

Make deliverables Review Technical Data Management Provide Data

Documentation Management Solutions

1

Professional Experience

Phases I-IV and Device

Premarket Approval (PMA)

(510)k Submission

Pharmacovigilance / Post Market Approval

Regulatory

Gary McLean

312 Marshcroft Way, Rolesville NC, 27571 / C: 919-***-****, H: 919-***-**** / ********@***.***

DRUG SAFETY CASE MANAGER Drug Safety Alliance October 2014 to Present

Review documents including medical records, reimbursements, financial statements, patient

enrollment forms and insurance claims to determine whether or not the document contains an

adverse event.

Record retrieval and review of the document into database. Entered necessary information after

review into safety database.

Write and review written conclusions for aggregate safety documents according to global

regulatory requirements.

Assisted in the evaluation of novel and computer assisted tools and methods for analysis of the

safety data.

Report data entry and quality control status to the Lead Clinical Specialist

Identify and document data problems during tracking, entry and quality control review of case

report form data

Review data for subjects enrolled in clinical research protocols based on edit

specifications.

Ensure data queries were generated in accordance to time agreements.

Clinical Data Coordinator Pra International May 2012 to July 2013

(Contract)

Prepare Ad Hoc reports for Listing Review and Lab Reconciliation

Conduct day to day Query Management and Discrepancy Review.

2

Analyze clinical data quality while reconciling Vendor Data, Protocol Deviation, and

eligibility assessments.

Write and test edit checks of multiple datasets, large and small, for eCRF pages.

Detect short term cycles in complex Time Series databases.

Process and review the CRF data of a subject enrolled in a trial.

Perform monthly reconciliation and reporting (adhoc listings, SAE, Pk, ECG labs) in

Excel to provide to study team.

Write ad hoc queries in a SQL environment to catch inconsistencies not found through

routine discrepancy management.

Reviewed work of others prior to sending discrepancy to field monitors.

Presented changes, provided suggestions, and presented to Study team the discussions in

client meetings. Determined how the changes and needs of the client will impact our

deliverables, while resourcing team members to effectively complete the task

Gary McLean

312 Marshcroft Way, Rolesville NC, 27571 / C: 919-***-****, H: 919-***-**** / ********@***.***

Use SAS Data Management to address potential data issues.

Generate SAS ad hoc reports to identify inconsistencies in processed data.

Create SAS Mapping spreadsheets to in order to query database for discrepant data.

Clinical Data Associate III INC Research April 2010 to January 2012

Maintained awareness of the pertinent elements of contract and scope of work for assigned

projects.

Provided oversight of Data validation and programming of edit checks.

Write SQL statements to perform adhoc reporting, and query the system for specific output.

Provide weekly and monthly Metrics to Leadership, team members, and clients in the Business

Objects tool.

Conducted UAT for Ancillary staff and managers.

Created and managed project plans, technical specifications, and change

management/version control practices.

3

Conducted weekly and monthly reports with R Programming to provide data analysis to

the both project teams.

Communicate with junior staff prior to queries being forwarded to sites and investigators.

Provide support for safety platforms, while working in and maintaining Oracle Argus

Safety software and databases.

Serve as liaison for client and staff to ensure consistency in Data Management Plan. a

Helped client understand workflow concept and strategy needed to adjust to process and

standards.

Reviewed draft DCFs, self-evident corrections and the application of global rulings,

proposed by less experienced Data Management staff.

Identified out of scope (OOS) changes, review of budgets, revenue, and participated in

monthly internal project reviews.

Write Data Entry Guidelines for input into Data Management Plan.

Provide input for Data Quality Plan and Clinical System Design Guide and draft sections

as assigned.

Create SAS mapping reports in order to reconcile inconsistent data.

Write CRF collecting and tracking instructions for Data and Project Management team.

Gary McLean

312 Marshcroft Way, Rolesville NC, 27571 / C: 919-***-****, H: 919-***-**** / ********@***.***

Resolved issues arising from quality control checks on listing output from database

against CRFs and DCFs.

Build SQL queries for analysis, reporting and GUI application.

Data Management Specialist bioMerieux March 2009 to April 2010

Assist in the building of databases in accordance with provided protocols.

4

Work closely with developers and DBA’s to ensure that data is mapped to the proper

tables, and that reference data has been loaded into the database prior to the data

transfer/migration.

Generate, resolve and track queries, while corresponding with field Monitors.

Develop functional and technical design specifications.

Ensured data from external databases/datasets such as laboratory databases, or electronic

diary datasets are consistent with data held on the CRF database with R Programming.

Annotate CRFs prior to database build, and development of edit check.

Pro-actively forward thinking while indentifying feasible cost effective technical

solutions to better assist the department and the client.

Triage departmental business request to identify if system is not working as designed and

tested.

Develop SQL queries to address system requirements and business needs.

Assist users to enter multiple rows of data from an excel spreadsheet, into a web-based

Data Entry system.

Develop test plans and test cases to analyze data required for integrating clinical datasets.

Provide weekly metrics to consistently analyze site monitoring and patient enrollment.

Lead Clinical Data Manager UCB/Schwarz Biosciences March 2008 to

December 2008

Coordinated all aspects of trial data management for clinical and safety data on assigned

trials.

Prepared and finalized trial specific data management manual according to company

SOPs.

Gary McLean

312 Marshcroft Way, Rolesville NC, 27571 / C: 919-***-****, H: 919-***-**** / ********@***.***

Organize and coordinate with CRF Vendors in designing all aspects of the CRF casebook

in accordance to standards and provided protocols.

Managed the database freeze and lock processes, and procedures.

Resolve, generate and track queries.

Ensure the electronic health record (EHR), design and build are consistent with company

standards.

5

Supported HIPAA electronic transactions.

Unit test creation and certification of system functionality.

Coordinate communication about future (EHR) changes, updates, and downtimes to

clinical staff.

Write Data Management Plan to be reviewed by the client, programmers, and Project

Management Team.

Suggest and provide Business Solutions in a cost effective way to best determine the

client’s needs, and our ability to provide a clean product in a timely manner.

Sr. Clinical Data Coordinator Sanofi-Aventis September 2007 to February

2008

Assisted in the design of Case Report Forms.

Help write and add to Data Management Plan by reviewing of the protocol and basic

version of the CRF.

Write and test edit specifications.

Perform database validation.

Annotate CRFs in Adobe and BlueBeam applications.

Create and managed data clarification forms.

Review and assisted in SAE Reconciliation.

Clinical Data Scientist II GSK/Clinforce June 2006 to December

2006

Provide SAS data quality metrics and feedback to clinical monitors and study site

personnel

Team to build CRFs in accordance to protocol and specific endpoints.

Conduct database and CRF validation.

Create scripts to test Web applications via LoadRunner.

Responsible for ensuring that documentation, code changes, are checked into the Version

control depository.

Generate, resolve and track queries in a clinical database.

Served as Lead of a project team of 4 clinical data coordinators.

Worked on numerous recovery studies while performing data management duties within

the studies.

Gary McLean

312 Marshcroft Way, Rolesville NC, 27571 / C: 919-***-****, H: 919-***-**** / ********@***.***

Contact sites to ensure the timely return of data clarification forms.

Lead Data Manager Covance June 2005 to June

2006

Serve as the primary Data Management contact for study team and sites.

6

Technical leader on all data management aspects for projects including start-up,

maintenance, and completion activities.

Develop Global Data Management Plans to deliver accurate, timely, consistent,

and quality clinical data.

Produce and test data management system edits, data validation checks and

special listings.

Produced ancillary reports (e.g., Special listings, Reconciliation discrepancy listings) used

to support the review of trial data.

Interfaced with customer to recommend technical and business solution for functionality

requirements with java.

Studied the feasibility between custom online tracking system developed in-house and

improve workflow.

Perform data transfers to client for consistent data workflow and correct analysis derived

from the project specific database.

Clinical Data Coordinator II Quintiles January 2005 to June 2005

Review clinical trial data in accordance with Global Data Management Plans and

applicable standardized data management processes (SOPs and Work Instructions).

Performed reconciliation of the clinical and safety databases.

Assisted in the development of the clinical data model and/or database design and

annotations of the CRF(eCRF) according to specifications.

Validating of data entry screens and provide feedback to study lead.

Review and verify data entry of team members.

Provide discrepancy management with limited supervision.

Generate, resolve and track queries in a clinical database.

Gary McLean

312 Marshcroft Way, Rolesville NC, 27571 / C: 919-***-****, H: 919-***-**** / ********@***.***

Clinical Data Administrator PPD, Inc May 2004 to December 2004

Responsible for document management, data entry, and implementation of CRF design

into designated software.

Ensured that all data validations were complete and screened through discrepancy

database

7

Help to develop and maintain clinical trial databases and validate programmed checks

used to clean the data.

Validating of data entry screens and provide feedback to study lead.

Provide reports for complete, incomplete, and missing CRF pages for multiple studies.

Therapeutic Experience

Infectious Diseases / Immunology

Oncology: Leukemia, Breast Cancer

Cardiovascular

Hematology

Central Nervous System

Psychiatry/Psychology: Schizophrenia

Respiratory: Chronic Obstructive Pulmonary Disease (COPD)

Renal: Chronic Kidney Disease

Ophthalmology

Education

North Carolina Central University

Computer Experience

Microsoft Word, Excel, PowerPoint, Access, SQL, PL/SQL, Lotus Notes, SQL

Developer, AMDOCS, OLTP, Adobe Writer, Oracle, Oracle Clinical, ClinTrial, ClinPlus,

Inform, Medidata Rave, Wyeth Application Frameworks, CTMS, CDASH, CDISC, SAS,

Javascript, SQL Developer, RDC, R Programming, Inbound Receipt and Triage ( IRT)

Safety Database, MedDra, WhoDrug, Salesforce, Oracle Argus Safety Database, Open

Clinica, Business Objects, HP/Unix

Publications and Presentations

2008 Full Data Management platform for Investigator Meeting in Washington, D.C.

2007 Provide presentation of IND for sponsor drug to the client.

Clinical Data Management Society

8

9

10

Contact this candidate