Protocol Development Specialist - (Healthcare - 2 year FTC - Renewable)

SUMMARY:
Background:

• Our client is an award-winning global clinical research organisation in the Durban area
• They undertake research in HIV, TB and Covid

POSITION INFO:
Contract Period: 2 year Fixed Term Contract - Renewable

Responsibilities:

• Develop and maintain Standard Operating Procedures relevant to the portfolio
• Develop protocol templates for early phase clinical studies, Phase I trials, Phase I first in Human studies to Phase III trials
• Develop standardized VM-CTU case report forms in conjunction with the Trial Data Manager, Statisticians, Clinical, Laboratory Investigators and Behavioural Scientists (where applicable)
• Work with Principal Investigators, Regulatory Manager, Trial Study Coordinators & Science Support Leads to obtain necessary information to complete trial protocols in advance of regulatory and funder submission dates
• Lead protocol writing meetings with the VM-CTU Principal Investigator, Individual Trial PIs and others as needed
• Manage the rapid update of protocols where needed and work with the Regulatory Manager to create and distribute letters of amendment & clarification memos
• Update the Investigators Brochure (for all investigational products) routinely as new data becomes available with the Sponsor and ensure coordination with Regulatory Manager
• At the end of each trial, draft the Clinical Study Report & work with the Statisticians, Investigators and Data Management to finalize
• Support the trial Principal Investigators with medical writing and presentation preparation

• Master’s Degree in Science, Medicine, Immunology, Microbiology, Public Health or associated allied health professions
• PhD would be advantageous
• Previous clinical trial experience
• Experience with clinical trial protocol and case report form development
• Experience with producing annual drug safety update reports for SAHPRA
• Experience with clinical study report & medical writing
• Publication track record in quality peer reviewed journals
• ICH (R3) and SA GCP Certification
• Proficient on MS Office and MS Project

• Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
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• Closing Date: 10 October 2025
• Note: No CV will be accepted after the closing date