Palesa Ranoha

I’m currently a Clinical Data Team Lead working in Contract Research Organizations (CROs), expertly gathering and analyzing data for clinical trials. I have operational experience that has spanned the full duration of studies, from study start-up to final database lock, managing of the documents and review process for the internal team. The role requires accuracy and skill for decisiveness as well as a strong sense of quality control due to tight timelines. Training of the internal team and managing of tasks or activities on the projects to ensure minimal errors and handling of challenges with understanding the client expectations. 

PPD - THERMO FISHER                                      

Senior Clinical Data Team Lead

Nov 2021- Present

      Demonstrates full competence when conducting the following tasks: 

• Writing metrics and providing outcome reports or monitoring metrics
• Manage a team of reviewers to ensure that they comply with SOPs and internal processes. 
• Review SOPs and working instructions to assist in coming stuff on the processes.
• Development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers
• Ensuring processes are followed as per protocol-specified parameters, is in the correct format, and data populates to the specified fields sectors.
• The primary contact for internal and external team members regarding processes and data management activities.
• Timelines creation and oversees timeliness of activities and expectations are meet.
• Project management, tasks, and the overall process assigned projects. 
• Provide training to the internal and external counter parts to help meet expectations.
• Conduct communicates modes that are proactive to stakeholders on any data management related deliverables. 

PRA HEALTH SCIENCE                                       

Lead Data Manager

Nov 2020 – Oct 2021

Demonstrates full competence when conducting the following tasks: 

• Assist with development the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
• Review to ensures electronic vendor data contains all protocol-specified parameters, is in the correct format, and data populates to the specified fields and patients correctly.
• Serves as the primary contact for internal and external team members regarding data management activities.
•  Develops timelines and oversees timeliness of data management activities during the life cycle of studies.
•  Tracks milestones, tasks, and the overall budget for assigned projects. 
• Communicates proactively to all internal and external stakeholders on any data management related deliverables. 
• Forecasts units, hours, and resourcing for data management tasks
•  Authors documents such as Data Management Plans, interim lock plans, database closure plans, and database unlocking plans
• Participates in client and/or third-party audits for data management.

IQVIA     

Associate Data Team Lead  

Jul 2018 – Oct 2020

Demonstrates full competence when conducting the following tasks: 

• Work with clinical staff to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning normal ranges and maintain proper documentation. 
• Enter (programme into edc) and perform QC for local laboratory normal ranges. Verify that normal ranges are properly attached to patient results in the local lab data collection module.
• Communicate to vendors and client problems involving data transfers, data point issues, and validation issues.
• Review data discrepancies generated by study-specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
• Performs reconciliation between vendor data and EDC data.
• Good understanding of GCP/ICH guidelines and FDA regulations.
• Responsible for data management processes from study start up to lock.
• Resolve all data management study processing activities (data entry, CRF tracking, ect.)
• Assign study tasks to the team and ensure timeline are met.
• Development of study tracking metric report for study team 
• Oversee execution of UAT of study specific systems
• Performing/ leading functional QC activities and testing 
• CRF Completion Guidelines and reconciliation Guidelines updates
• Ability to work independently and display positive attitude towards client.
• Lead data management projects with oversight management
• Willingness to learn new skill and expand knowledge of drug development.

MMS Holdings Inc.                                             

Associate Data Team Lead

May 2017 – Jun 2018

Demonstrates full competence when conducting the following tasks: 

• Good understanding of GCP/ICH guidelines and FDA regulations.
• Responsible for data management processes from study start up to lock.
• Resolve all data management study processing activities (data entry, CRF tracking, ect.)
• Assign study tasks to the team and ensure timeline are met.
• Development of study tracking a metric report for study team 
• Oversee execution of UAT of study specific systems
• Performing/ leading functional QC activities and testing 
• CRF Completion Guidelines and reconciliation Guidelines updates
• Ability to work independently and display positive attitude towards client.
• Lead data management projects with oversight management
• Willingness to learn new skill and expand knowledge of drug development.

PAREXEL International Limited, GRO, 

Clinical Data Analyst II, 

 August 2015 – April 2017

Demonstrates full competence when conducting the following tasks: 

• Development of database build specifications 
• SPOC: Study point of contact, keep contact with study team.
• Provide monthly study status and full study matrix.
• Assign study tasks to the team and ensure timeline are met.
• Development of data validation specifications 
• Test data creation & UAT 
• Performing/ leading functional QC activities and testing 
• Create CRF Completion Guidelines, SAE reconciliation Guidelines, 
• Data validation and cleaning 
• Conduct medical coding. 
• 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 and quality of clinical data 
• Learning role of Primary CDA 
• Support site personnel to retrieve missing data as required. 

Quintiles Transnational, 

Clinical Data Coordinator,

 August 2011 – July 2015 

• Conduct basic data review.
• Serve as Data Operations Coordinator (with guidance).
• Solve issues through using the global issue escalation/communication plan. 
• Write data clarifications as directed by the Data Operations Coordinator.
• Resolve data clarifications, as directed by the Data Operations Coordinator.
• Meet personal project objectives, as assigned by manager.
• Interact with CDM team members to negotiate timelines and responsibilities. 
• Escalate problems to the attention of the Data Operations Coordinator or Group Manager.
• Understand and comply with core operating procedures and working instructions.
• Develop and maintain good communications and working relationships with CDM team. 
• Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
• Provide data review training within the team and assist with quality review.
• Meet objectives as assigned.

INPRROGRESS (Complete by 2024)                 POST GRADUATE DIPLOMA IN PUBLIC HEALTH          

UNIVERSITY OF PRETORIA                            

SUBJECTS PASSED    

• Learning in Public Health
• Introduction to Environmental Health
• Introduction to Research Methodology

QUALIFICATION OBTAINED                            BASICS OF TOTAL QUALITY MANAGEMENT 

UNIVERSITY OF SOUTH AFRICA                    (Short Learning Program)

SUBJECT PASSED

• The Human Components and Tools and Techniques for TQM
• Quality Management Systems and TQM Implementations

QAULIFICATION OBTAINED                            BSc. BIOCHEMISTRY

UNIVERSITY OF THE FREE STATE

SUBJECTS PASSED

• Biochemistry
• Microbiology
• Genetics