Summary
Overview
Work History
Education
Skills
Accomplishments
References
Training
Timeline
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TEMHLANGA DLAMINI

Matsapha,MA

Summary

A highly skilled and dynamic Monitoring and Evaluation Officer with 5+ years’ experience in programmatic research, monitoring and/or evaluation. Highly motivated creative and innovative data management professional with experience in data management, statistical reporting, data collection tool design and implementation in accordance to program requirements. Experienced in ensuring timely and accurate collection and reporting of programmatic data within respective cohorts and categories and ensuring high performance of project databases.

Overview

6
6
years of professional experience

Work History

Data Quality Officer – Clinical Research

ICAP ESWATINI
06.2021 - 09.2023
  • Clinical studies conducted: HPTN084, COVPN3008 Buntu, Insight Study, HPV Vaccine Study
  • Created and managed data storage and retrieval systems according to site SOPs.
  • Supported data entry into RedCap, Medidata Rave, and DFExplore databases and troubleshooted database issues.
  • Developed and maintained systems that support timely and high-quality data collection and entry, including Standard Operating Procedures (SOPs), trackers, and other tools including capacity planning, data maintenance, and security.
  • Developed and performed data queries and data cleaning as required in accordance with study SOPs and Clinical Quality Management Plan.
  • Performed site internal monitoring including review of investigator site file, trial master file, laboratory, and pharmacy file in accordance with regulatory requirements and ICH GCP guidelines.
  • Evaluated quality and integrity of study site practices related to the proper conduct of protocol and adherence to applicable regulations and escalated quality issues appropriately.
  • Conducted quality and data-related training related to the proper conduct of protocol and sponsor requirements.
  • Created and maintained appropriate documentation regarding site internal monitoring findings and action plans by submitting and filing regular quality reports, and other required study documentation.
  • Provided monthly, quarterly, semi-annual, and annual statistical reports in a timely manner.
  • Performed periodic maintenance of study computers and electronic devices to review encryption and password controls.
  • Conducted periodic backups on all local databases, trackers, and all participant/patient electronic files.

Data Quality Officer

FAMILY LIFE ASSOCIATION OF SWAZILAND
09.2019 - 05.2021
  • Manage participant files, including assembly of blank files, retrieval and filing
  • Support data entry into electronic data capture databases
  • Develop and maintain systems that support timely and high-quality data collection and entry, including Standard Operating Procedures (SOPs), trackers and other tools
  • Work with the clinical/laboratory teams to ensure timely data into Medidata rave and timely resolution of data queries
  • Develop and perform data queries and data cleaning as required in accordance with study SOPs and the CQMP
  • Coordinate the process of addressing and correcting data queries and updating the database by liaising with study physician, study nurses, pharmacy team and laboratory team
  • Conduct regular QA/QC activities according to the CQMP
  • Produce reports of internal data and quality monitoring and to guide and assess site operations
  • Conduct trainings/re-fresher trainings on data and quality aspects of the study as needed
  • Collaborate with the HPTN retention team to manage the HPTN SMS system to ensure that the SMS intervention is fully functional and continuously up to date
  • Manage access to the data room, study computers and filing cabinets to ensure data security, participant confidentiality, segregation of PII, and systems to facilitate easy retrieval of files and study documents
  • Perform periodic maintenance of study computers and electronic devices to review encryption and password controls
  • Conduct periodic backups on all local databases, trackers and all participant/patient electronic files.

Data Clerk – HPTN084 Clinical Trial

FAMILY LIFE ASSOCIATION OF SWAZILAND
06.2018 - 08.2019
  • Conduct filing of study participant binders
  • Conduct daily reviews of each CRF before doing data entries to Medidata rave
  • Ensure data is entered into Medidata rave on time
  • Always ensure availability of blank forms and prepare binders on a daily basis
  • Review and reconcile data queries and inform data manager if necessary
  • Write data quality assurance /study monitoring reports as needed
  • Ensure participant confidentiality at all times in the data room
  • Ensure data is stored in a safe and secured manner in line with GCP standards
  • Ensure that all hardcopy participant information in the data office will be kept in a lockable cabinet
  • Ensure that all electronic records are kept in a computer that is encrypted and has password controls with limited access to non-study staff
  • Ensure to the adherence to data collection procedures and tools.

Data Officer – ECHO Study

FAMILY LIFE ASSOCIATION OF SWAZILAND
02.2018 - 10.2018
  • Conduct filing of study participant binders
  • Conduct daily reviews of each CRF before faxing
  • Ensure CRFs are faxed within 48 hours
  • Always ensure availability of blank forms and prepare binders on a daily basis
  • Review and reconcile data queries and inform data manager if necessary
  • Write data quality assurance /study monitoring reports as needed
  • Ensure participant confidentiality at all times in the data room (all participant information will be kept in a locked cabinet and in a locked room)
  • Ensure data is stored in a safe and secured manner in line with GCP standards
  • Ensure that all hardcopy participant information in the data office will be kept in a lockable cabinet
  • The data officer will ensure that all electronic records are kept in a computer that is encrypted and has password controls with limited access to non-study staff
  • Ensure to the adherence to data collection procedures and tools.

IT Projects Officer

TECHNOLOGY SOLUTIONS AFRICA (PTY) LTD
04.2017 - 01.2018
  • Prepared and made presentations to potential clients on IT systems and solutions, met with clients to finalize deals and purchases
  • Led in preparation of project plans, user requirements, conducting site assessments to ensure adequate resource planning for projects
  • Worked with Operations Manager and Accounts Officer to budget for IT projects and purchase all equipment required and ensure that it meets client’s requirements
  • Work with IT technicians and finance and logistics department to ensure that transport and equipment was available to conduct projects
  • Provide first line of support for users of IT systems (clients & in-house)
  • Conducted periodic visits to client sites for service of equipment and to ensure that all systems are functioning as expected
  • Liaise with vendors and suppliers to purchase IT equipment and consumables.

Education

Bachelor of Science in Computer Science and Geography, Environmental Science & Planning -

University of Swaziland
Kwaluseni, Manzini
10.2016

Skills

  • Experience maintaining databases: Medidata Rave, Emmes Advantage eClinical, RedCAP
  • Advanced computer skills in Excel, Word, Database design and management and statistical packages (SPSS and Stata)
  • Excellent interpersonal and teamwork skills
  • Excellent written and spoken communication skills
  • Languages: Fluency in English and Siswati
  • Data research and analysis
  • Data Quality Monitoring
  • Data quality assurance processes

Accomplishments

    Awarded the EEC Computer Science Prize for being the best student in the Uniswa graduating class of October 2016

References

1. Celani Nkambule, Study Manager- Clinical Research (CoVPN3008) ICAP Eswatini

cn2514@cumc.columbia.edu

(+268) 76347032 / (+268) 79347032


2. Nothando Sihlongonyane, Study Manager- Clinical Research (HPTN084) ICAP Eswatini

nottysi58@gmail.com

(+268)76396889


3. Veli Madau, Founder and Director Siyavelana Organisation, Former Quality Manager-ICAP Eswatini

velim@siyavelana.com

(+268) 76076815

Training

Good Clinical Practices (GCP) Human Subjects Protection (HSP) HIPAA: Health Insurance Portability Accountability Act Research

Timeline

Data Quality Officer – Clinical Research

ICAP ESWATINI
06.2021 - 09.2023

Data Quality Officer

FAMILY LIFE ASSOCIATION OF SWAZILAND
09.2019 - 05.2021

Data Clerk – HPTN084 Clinical Trial

FAMILY LIFE ASSOCIATION OF SWAZILAND
06.2018 - 08.2019

Data Officer – ECHO Study

FAMILY LIFE ASSOCIATION OF SWAZILAND
02.2018 - 10.2018

IT Projects Officer

TECHNOLOGY SOLUTIONS AFRICA (PTY) LTD
04.2017 - 01.2018

Bachelor of Science in Computer Science and Geography, Environmental Science & Planning -

University of Swaziland
TEMHLANGA DLAMINI