Clinical Trial Operations Manager (WHC)

SUMMARY:
Background:

• Wits Health Consortium (Pty) Limited ("WHC") is a wholly-owned Company of the University of the Witwatersrand, Johannesburg (South Africa) under its Faculty of Health Sciences. WHC provides Faculty with a legal framework within which to operate the research and other activities necessary to support its academic objectives
• In addition, WHC offers a range of products and services to Academics

• The Mycology Division aims to improve the outcomes of people affected by serious, life- threatening fungal diseases in South Africa and the African region through public health-focused epidemiological, clinical and basic science research and innovation
• Our work also stretches to other important infectious diseases CombAT Candida is an observational study of the prevalence, colonization rates and infection rates of Candida in South African hospitals
• This will lead into a clinical trial evaluating invasive candidiasis treatment options

POSITION INFO:
Main purpose of the job:

• The post-holder will be responsible for overall management and coordination of an observational study and a multisite phase 3 randomised clinical trial of antifungal treatment for candidemia (COMBAT Candida), which will take place at 5 hospital sites in Johannesburg
• As a member of the trial management group in South Africa, they will work closely with the project co-ordinator, co-investigators, trial epidemiologist and statisticians in the UK, the site investigators and study coordinators at the study sites, the laboratory scientists, lead clinician, data management and administration team at Wits Mycology
• The applicant will be expected to be based full-time at the coordinating site in Johannesburg for the duration of study recruitment

• 1 Modderfontein Road, Sandringham, Johannesburg

• Day to day management of the phase 3 clinical trial and ensuring compliance with the study protocol and international standards of Good Clinical Practice (GCP)
• Coordinating applications to ethical and regulatory bodies
• Perform site visits for trial set up and initiation, regular monitoring visits during patient recruitment, and close out visits on trial completion
• Organising and facilitating meetings and assisting with communications, including Trial Management Group, Trial Steering Committee, Investigator, and Data Monitoring Committee meetings
• Liaising with study sites, the data management team, and study epidemiologists and statisticians to ensure follow-up information is kept up-to-date, accurately completed and that loss of patient data is prevented
• Ensure that all trial adverse events are appropriately investigated by the study staff and accurately reported to the principal investigators
• Maintaining liaison with partner institutions and funders
• To assist with organisation and coordination of related projects and funding applications where necessary, to procure required trial consumables and monitor the trial budget
• To assist the chief and co-investigators with preparation of trial materials including updated protocol, consent, patient information, case record and adverse event forms and standard operating procedures for trial sites
• To visit hospital sites for purpose of trial set-up and initiation, and monitoring, and co-ordinate and promote communication between the centres and the trial coordinating centre, allowing early recognition and resolution of any difficulties
• To prepare research progress and monitoring reports for, organise and minute regular meetings with the Trial Management Group, Trial Steering Committee and Data Monitoring Committee
• To organise meetings, as necessary, with study team members and collaborators, including programmes, accommodation, travel, venues and social events

• Higher education to a degree level or equivalent in Health Sciences

• Minimum 3 years experience in the conduct of multi-centre clinical trials in South Africa
• Proven experience of managing projects with multiple partners
• Experience of work within a higher education institution or similar environment

• Postgraduate qualification in Public Health
• Project management qualification
• GCP certification
• Proven experience of co-ordination of international phase 3 clinical trials
• Proven experience in infectious diseases research

• 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 above criteria will not be considered for the respective position
• Wits Health Consortium will only respond to shortlisted candidates
• Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful
• Closing date: 27 June 2025
• Note: No CV will be accepted after the closing date

• WHC, in accordance with its Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto
• AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium
• AJ Personnel does not have any salary or other information regarding the position