Summary
Overview
Work History
Education
Skills
Timeline
RegisteredNurse

Elmarie Viljoen

Data Management Lead II
Bloemfontein

Summary

As a Clinical Data Management Lead at PAREXEL, I am responsible for all data processing tasks and deliverables on assigned data processing projects, ensuring completeness, timely delivery, and quality of clinical data. With over 16 years of experience in this role, I have developed and refined my skills in data management, data validation, data cleaning, medical coding, database QC, and database lock activities.

I lead and coordinate other team members within the department on moderately assigned studies or multiple small protocols, mentoring them and providing subject matter expertise when needed. I also represent the Data Management function in external client meetings and presentations, such as investigator meetings, as required. My mission is to facilitate and enable the successful conduct of clinical trials by providing high-quality data processing solutions and services.

For the last 6 months I have been standing in as a Data Engineer. I am primarily responsible for setting up the File Transfer Specifications. Working closely with vendors to ensure timely completions and transfers.

When needed I provide on the job training to new team members. I am also involved with providing refresher training sessions to the study teams as Subject Matter Expert (SME)

Overview

25
25
years of professional experience
2
2
Languages

Work History

Data Management Lead II

PAREXEL, International
02.2021 - Current
  • Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications.
  • Ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
  • Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave.)
  • Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system (MyTrials, IVRS etc.) and Reporting functionality within the EDC system)
  • Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation
  • Thorough knowledge of all activities during Study Maintenance and Database Lock. Review of metrics to determine risks and risk mitigation plans as required
  • Effectively communicate to and manage internal project teams, external customers and third-party vendors. Hold team meetings on a regular basis. Participate in client, investigator and team meetings.
  • Effectively manage contracted project delivery. Highlight issues/risks to delivery and mitigate risks for both PAREXEL and the client, developing contingency plans for the project (or providing input to PL). Accountable for quality control of project deliverables and timely delivery of projects.
  • Manage appropriate project level resourcing of staff and staff assignments. Identify and request staff necessary for the project team.
  • Ensure information entered into management systems is accurate and updated on a regular basis.
  • Review metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.
  • Participate in cross functional meetings and drive initiatives, participate in Business Development and BID defence meetings as required.
  • Prepare, participate in and follow up on audits/inspections.
  • Participate in meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client.
  • Collaboration with the Clinical team to review the ClinBase setup performed by the pharmacy, safety Laboratory team and Clinical Database Designer.

Associate Data Management Lead

PAREXEL, International
05.2020 - 01.2021
  • Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications.
  • Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave.)
  • Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system (MyTrials, IVRS etc.) and Reporting functionality within the EDC system)
  • Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation
  • Thorough knowledge of all activities during Study Maintenance and Database Lock. Review of metrics to determine risks and risk mitigation plans as required
  • Effectively communicate to and manage internal project teams, external customers and third-party vendors. Hold team meetings on a regular basis. Participate in client, investigator and team meetings.
  • Effectively manage contracted project delivery. Highlight issues/risks to delivery and mitigate risks for both PAREXEL and the client, developing contingency plans for the project (or providing input to PL). Accountable for quality control of project deliverables and timely delivery of projects.
  • Manage appropriate project level resourcing of staff and staff assignments. Identify and request staff necessary for the project team.
  • Ensure information entered into management systems is accurate and updated on a regular basis.
  • Review metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.
  • Participate in cross functional meetings and drive initiatives, participate in Business Development and BID Defence meetings as required.
  • Prepare, participate in and follow up on audits/inspections.
  • Participate in meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client.
  • Collaboration with the Clinical team to review the ClinBase setup performed by the pharmacy, safety Laboratory team and Clinical Database Designer.

Clinical Data Analyst III

PAREXEL, International
11.2018 - 04.2020
  • Development of database build specifications
  • Development of data validation specifications
  • Test data creation & UAT
  • Performing/ leading functional QC activities and testing
  • Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
  • Data validation and cleaning
  • Conduct medical coding if assigned
  • Conduct SAE & third-party data reconciliations
  • Perform early and final database QC activities
  • Database lock activities
  • Maintaining Clinical Study Documents and archiving as appropriate
  • Responsible for completeness, timely delivery and quality of clinical data
  • Lead and coordinate other team members within the department on moderately assigned studies or multiple small protocols
  • Mentor project team members and be a subject matter expert when needed
  • Represent Data Management (DM) function in external client meetings and presentations such as investigator meetings as required. May represent PAREXEL at professional meetings / conferences
  • Other assigned responsibilities as needed

Clinical Data Analyst II

PAREXEL, International
02.2016 - 11.2018
  • Development of database build specifications
  • Development of data validation specifications
  • Test data creation & UAT
  • Performing/ leading functional QC activities and testing
  • Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
  • Data validation and cleaning
  • Conduct medical coding if assigned
  • Conduct SAE & third-party data reconciliations
  • Perform early and final database QC activities
  • Database lock activities
  • Maintaining Clinical Study Documents and archiving as appropriate
  • Responsible for completeness, timely delivery and quality of clinical data
  • Lead and coordinate other team members within the department on moderately assigned studies or multiple small protocols
  • Mentor project team members and be a subject matter expert when needed
  • Represent Data Management (DM) function in external client meetings and presentations such as investigator meetings as required. May represent PAREXEL at professional meetings / conferences
  • Other assigned responsibilities as needed

Clinical Data Analyst III

PAREXEL, International
11.2011 - 01.2016
  • Development of database build specifications
  • Development of data validation specifications
  • Test data creation & UAT
  • Performing/ leading functional QC activities and testing
  • Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
  • Data validation and cleaning
  • Conduct medical coding if assigned
  • Conduct SAE & third-party data reconciliations
  • Perform early and final database QC activities
  • Database lock activities
  • Maintaining Clinical Study Documents and archiving as appropriate
  • Responsible for completeness, timely delivery and quality of clinical data
  • Lead and coordinate other team members within the department on moderately assigned studies or multiple small protocols
  • Mentor project team members and be a subject matter expert when needed
  • Represent Data Management (DM) function in external client meetings and presentations such as investigator meetings as required. May represent PAREXEL at professional meetings / conferences
  • Other assigned responsibilities as needed

Clinical Data Analyst II

PAREXEL, International
04.2009 - 11.2011
  • I worked as Back-up for the task lead on coding, and I am Primary Coder on eleven studies
  • Working as part of a team
  • The CDA’s essential function is to perform all clinical data management activities on assigned projects, commensurate with experience and /or project role
  • Data validation
  • Raising and integrating queries
  • Understanding of clinical coding concepts
  • Review of electronic data
  • SAE reconciliation
  • This may also involve database initiation, set up and lock activities
  • Work to the appropriate standards of quality and efficiency

Clinical Data Manager I

PAREXEL, International
05.2008 - 03.2009
  • Acting as Back-up for the task lead on coding and Primary Coder on four studies
  • The CDM’s essential function is to perform all clinical data management activities on assigned projects, commensurate with experience and /or project role
  • Data validation
  • Raising and integrating queries
  • Understanding of clinical coding concepts
  • Review of electronic data
  • SAE reconciliation
  • This may also involve database initiation, set up and lock activities
  • Work to the appropriate standards of quality and efficiency

Data Entry Operator I

PAREXEL International
01.2008 - 04.2008
  • Enter clinical trials data on the appropriate database
  • Follow departmental and project guidelines
  • Perform project tasks in accordance with project timelines
  • Keep manager informed about work progress and any issue
  • Utilize appropriate TIME codes for the tasks and projects
  • Maintain agreed utilization level

CAD Operator I

THM Engineers
01.2006 - 12.2007
  • Compilation of several documents for tender purposes
  • Technical Drawings on CAD (Computer-aided design)

Technical Admin

Scottish Water Solutions
11.2004 - 10.2005
  • Perform several administrative tasks. Assisting the Project Manager in her daily tasks

Auxiliary Services Officer I

Department Of Water Affairs And Forestry
01.1999 - 06.2004
  • Enter Farmer’s irrigation data on the WARMS database
  • Give appropriate training to new temporary employees on the WARMS database
  • Verify entered information captured by the temporary employees
  • Drawing up of dam contour plans from survey information

Education

High School Diploma -

HTS Middelburg
Middelburg, South Africa
04.2001 -

Skills

Problem-Solving

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Timeline

Data Management Lead II

PAREXEL, International
02.2021 - Current

Associate Data Management Lead

PAREXEL, International
05.2020 - 01.2021

Clinical Data Analyst III

PAREXEL, International
11.2018 - 04.2020

Clinical Data Analyst II

PAREXEL, International
02.2016 - 11.2018

Clinical Data Analyst III

PAREXEL, International
11.2011 - 01.2016

Clinical Data Analyst II

PAREXEL, International
04.2009 - 11.2011

Clinical Data Manager I

PAREXEL, International
05.2008 - 03.2009

Data Entry Operator I

PAREXEL International
01.2008 - 04.2008

CAD Operator I

THM Engineers
01.2006 - 12.2007

Technical Admin

Scottish Water Solutions
11.2004 - 10.2005

High School Diploma -

HTS Middelburg
04.2001 -

Auxiliary Services Officer I

Department Of Water Affairs And Forestry
01.1999 - 06.2004
Elmarie ViljoenData Management Lead II