Summary
Overview
Work History
Education
Skills
References
Personal Information
Accomplishments
Certification
Languages
Websites
Affiliations
Timeline
AssistantManager

Thobi Cynthia Diamond

Randburg

Summary

With over seven years of experience in clinical research, I have built a solid foundation across diverse roles, including five years in data management and three years in clinical operations. My career began in data management, where I developed strong analytical and organizational skills, ensuring high-quality data collection, and compliance with regulatory standards. Driven by curiosity and a passion for professional growth, I transitioned into Clinical Operations, joining the CRA Academy with ICON pharma.

I gained a hands-on experience as an In-house CRA, where I supported field CRAs by tracking site performance, managing investigator communications, and ensuring protocol compliance. My role emphasized collaboration, problem-solving, and attention to detail, which directly contributed to the success of site monitoring. These attributes of technical expertise, operational insights, and a commitment to excellence positions me as a valuable asset in the field of clinical research.

Overview

7
7
years of professional experience
1
1
Certification

Work History

In-House CRA

ICON
Johannesburg
11.2022 - Current
  • Collect, review & distribute Essential site documents
  • Set-up and upload essential documents in eISF (Florence)
  • Ensure CTMS and other systems are kept up to date
  • For SIP Studies, ensure Study Site Profile information is maintained in SIP by PI or Delegate
  • Collect Essential Documents at study-start and throughout the duration of the trial through completion
  • Clinical and non-clinical supply management, in collaboration with other country roles
  • Update manuals/documents (patient diaries, instructions)
  • Organize, manage, and present internal study meetings
  • Contribute and manage country/site correspondence and monitor adherence and disclosures
  • Collect all required Site Level Documents for IRB/IEC & RA Submissions
  • Ensure all required documentation for clinical supplies shipment to sites (per EDA requirements) are in place in eTMF
  • Provision systems access and assign protocol specific trainings
  • Filling, Tracking and QC of essential documents in eTMF (Veeva Vault)
  • Support preparation of submission package for IRB/ERC and regulatory agencies
  • Experience in utilizing the following systems: - Siebel Clinical Trial Management System (CTMS), SPECTRUM, eTMF, EDC, FLORENCE, and SIP
  • Ensure study maintains patient safety and privacy standards
  • Calculate & execute payments to (investigators, vendors, grants)
  • Arrange/Liaise with METROFILE (off site storage vendor) for site document archival
  • Support new CRAs and site personnel with procedural guidance and study specific information
  • Manage Labeling requirements, update manuals (patient diaries, instructions)

Clinical Research Associate (CRA 1)

ICON
Johannesburg
10.2021 - 10.2022

· Support the submission of regulatory packages and IRB/IEC submissions.

· Ensure proper documentation in line with regulatory standards, Good Clinical Practice (GCP), and sponsor requirements.

· Collaborate in the preparation for site initiation visits (SIVs), including document collection, organize study files, including the trial master files (TMF), and essential study documentation.

· Serve as a point of contact for clinical sites to answer questions, provide guidance, and resolve issues.

· Support site initiation, monitoring, and closeout activities remotely. Coordinate with sites for timely completion of study milestones, and track site performance.

· Conduct remote monitoring of clinical sites to assess protocol compliance, patient safety, and data quality.

· Identify and escalate protocol deviations, data discrepancies, or compliance issues to the appropriate team members.

· Perform regular data reviews to identify inconsistencies or missing information.

· Generate, track, and resolve data queries with clinical sites and the data management team.

· Assist in the planning and coordination of clinical trial activities, timelines, and deliverables.

· Collaborate with cross-functional teams, including regulatory, data management, and clinical operations.

· Coordinate investigational product (IP) and study supply shipments, ensuring that sites have the necessary materials.

· Prepare and distribute study-related reports, including site performance and status updates.

· Document interactions with clinical sites, maintain correspondence logs, and ensure follow-up actions are completed.

· Assist in training site staff on study protocols, processes, and compliance requirements.

· Support new CRAs and site personnel with procedural guidance and study-specific information.

Clinical Research Associate (CRA 1) ACADEMY

ICON
Johannesburg
09.2021 - 10.2021

The CRA academy was a program that was scheduled for 4 weeks which equipped us with knowledge, skills and some role-playing scenarios to prepare us for monitoring responsibilities. The academy provided valuable insights into clinical operations, complementing the experience I already gained, particularly in the field of data management. The program included:

1. Introduction to Clinical Research

History and phases of clinical trials. Drug development process. Roles and responsibilities of a CRA.

2. Regulatory Frameworks

Good Clinical Practice (GCP). International Council for Harmonisation (ICH) guidelines. FDA, EMA, and other global regulatory requirements.

3. Study Protocol design

Understanding Protocols and amendments. Informed Consent Process. Key clinical trial documents (e.g Investigator brochure, case report forms).

4. Site Management and Monitoring

Site selection and initiation. Conducting remote monitoring. Risk-based Monitoring principles.

5. Data Management and Quality Assurance

Handling source documents and verification (SDV). query generation and resolution.

6. Compliance and Ethics

Handling protocol deviations. Ensuring participant safety and data integrity.

7. Practical Training - Simulating site initiation, interim and close-out visits. Review mock patient records for source data verification. Document findings in monitoring visit reports

8. Role -Play Scenarios - Navigating challenging situations with site staff. Escalating compliance issues appropriately.

Clinical Project Specialist (PS)

PAREXEL
Bloemfontein
05.2016 - 10.2019
  • Set up Clinical Trial Projects
  • Start Up project planning, initiation, controlling, executing and close out
  • Set up project documents as per Standard Operating Procedures (SOP’s), templates, tools & systems
  • Conduct internal & client meetings
  • Executing data analysis & distribution of analytic reports to the team
  • Maintain Project Management Plan
  • Maintain Central Files
  • Management of payments
  • Invoicing the sites
  • Providing team trainings
  • Setting up client calls/meetings
  • Review of Meeting minutes
  • Discuss/share lessons learned with the team

Clinical Data Analyst (CDA)

PAREXEL
Bloemfontein
11.2014 - 04.2016
  • Responsible for a wide range of projects as main Serious Adverse Events Subject Matter Expert (SAE SME)
  • Conduct SAE reconciliation
  • Generate queries as required and follow up with the Safety Group (Medical Practitioners)
  • Tracking safety issues and integrate queries
  • Perform early and final database Quality Control
  • Update all relevant tracking system on an ongoing basis
  • Conduct in-house data review
  • Identify and report protocol violations
  • Train new hires

Data Operations Coordinator

IQVIA
Bloemfontein
05.2011 - 10.2014
  • Company Overview: Formerly Quintiles
  • Perform Manual Listings
  • Perform Lab reconciliation
  • Edit Data Management Plan
  • Conduct basic quality control procedures
  • Write data clarifications
  • Perform SAS Listings
  • Test database
  • Track and review CRFs
  • Resolve data clarifications
  • Perform IVRS Reconciliation
  • Edit Specifications
  • Develop project-specific status reports
  • Query Generation
  • Formerly Quintiles

Education

Post Graduate Diploma - Business Administration

UNIVERSITY OF THE FREE STATE
01.2019

Project Management Certificate -

01.2018

Bachelor of Sciences - Medical Microbiology

UNIVERSITY OF THE FREE STATE
01.2010

Master’s - business administration

UNIVERSITY OF THE FREE STATE

Skills

  • Interpersonal skills Communication skills Analytical skills Report writing Presentation skills Problem-solving skills Time management Conflict management Attention to detail Proficiency in Microsoft Excel Proficiency in Microsoft Word Proficiency in Microsoft PowerPoint
  • Key Competencies - Expertise in clinical data management and analysis Ability to manage complex tasks and prioritize effectively under tight timelines
  • Key Achievements - SAE SME, METROFILE SME (off site storage vendor)
  • Successfully transitioned from Data Management to Clinical Operations, diversifying my expertise Demonstrated adaptability and resilience by excelling in roles with shifting priorities and demands

References

  • Nos Tissang, ICON Line Manager, +27 76 419 7208, nos.tissang@iconplc.com
  • Zoltan Lamper, Clinical Operations Manager (ICON)- CRA Academy, +36 70 383 1295, zoltan.lamper@docsglobal.com

Personal Information

  • Ethnicity: African
  • Title: Mrs.
  • Gender: Female

Accomplishments

  • SAE SME
  • METROFILE SME (off site storage vendor)

Certification

  • ICH-GCP
  • Project Management

Languages

Isizulu
First Language
English
Advanced (C1)
C1
Afrikaans
Intermediate (B1)
B1
SeSotho
Intermediate (B1)
B1
SeTswana
Intermediate (B1)
B1

Affiliations

  • Fitness and Wellness: Dedicated to regular workouts, which have enhanced my time management, resilience, and ability to set and achieve long-term goals.

Timeline

In-House CRA

ICON
11.2022 - Current

Clinical Research Associate (CRA 1)

ICON
10.2021 - 10.2022

Clinical Research Associate (CRA 1) ACADEMY

ICON
09.2021 - 10.2021

Clinical Project Specialist (PS)

PAREXEL
05.2016 - 10.2019

Clinical Data Analyst (CDA)

PAREXEL
11.2014 - 04.2016

Data Operations Coordinator

IQVIA
05.2011 - 10.2014

Post Graduate Diploma - Business Administration

UNIVERSITY OF THE FREE STATE

Project Management Certificate -

Bachelor of Sciences - Medical Microbiology

UNIVERSITY OF THE FREE STATE

Master’s - business administration

UNIVERSITY OF THE FREE STATE
Thobi Cynthia Diamond