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 Minimum Requirements: Masters 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 TO APPLY: Only if you meet the minimum job requirements and experience as mentioned above , you may submit a detailed updated CV Please Apply Online and complete your registration via our website to enable and protect you as a candidate and to accept the new POPIA terms and conditions This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market Please take note that the applicants who do not adhere to the minimum requirements will not be considered for the respective position Note our clients may expire jobs at their own discretion AJ PERSONNEL will only respond to shortlisted candidates If you have not received a response within two (2) weeks from applying, your application was then unsuccessful for that specific position, however your profile remains on our system for future opportunities Closing Date: 10 October 2025 Note: No CV will be accepted after the closing date