Job Description

Main purpose of the job:

• To provide overall management of Clinical Trials or Clinical Programs, and Research studies within WITS DIH

Division:

• Wits Diagnostic and Innovation Hub

Location:

• Parktown - Johannesburg

Key performance areas:

• Review project protocols and gain understanding of the scope of laboratory requirements
• Drafting of quotes as per protocol requirements and study budgets
• Protocol interpretation and setting up of analytical plans
• Convert research protocol into workable analytical/ study plans to enable the laboratory staff to conduct necessary tests
• Serve as primary contact for the sponsor/ site for project initiation and planning
• Review project protocols and gain understanding of the scope of work and assist with services agreements if required for sponsor
• Converting research protocols into workable study documents to enable all laboratory staff to conduct the protocol testing
• Drafting of request forms and other study related documents
• Ensure project and protocol amendments are implemented as required
• To ensure that all study projects are set up according to Good Clinical Laboratory Practise (GCLP), Good Clinical Practise (GCP) and ISO standard
• Co-ordinate study on behalf of WITS DIH once it has commenced (e.g. shipping of samples, meetings with relevant staff, training staff, attendance to site initiation visit meetings, support at trial sites)
• Take primary responsibility for the response to project audit findings related to CT department specific to the project
• Prepare project plans, project status and other administrative reports and submit to sponsors as required by the contract with them, and other internal stakeholders
• Report timeously on project progress, the results of risk analyses, contingency plans, technical information, and input from team throughout the project
• Conduct all training for laboratory and site staff
• Process validation and ensure all dry run documents have been completed and reviewed by all WITS DIH departments
• Check for errors noted during dry run process that must be addressed and corrected before the study start
• Communicate any significant changes in resourcing, scope of work and timelines to all stakeholders including team members

Required minimum education and training:

• National Diploma and BTech degree in Biomedical Technology, or BSC in Health Sciences

Required minimum work experience:

• Minimum of 5 years working experience in Clinical Trials and in Project Management.

Professional body registration:

• HPCSA as a Medical Technologist

Desirable additional education, work experience and personal abilities:

• Completion of Good Clinical Laboratory Practice (GCLP) and Good Clinical Practice (GCP) courses will be advantageous.
• Must have a Clinical Trials exposure with LDMS and LIMS understanding.
• Project management experience will be advantageous.
• An understanding of project finance and budgets.
• Must be able to multitask, assertive, and customer oriented.

TO APPLY:

• Only if you meetthe 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: 26 May 2025
• Note: No CV will be accepted after the closing date.

Please note:

• 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 handlingon behalf of their client Wits Health Consortium.
• AJ Personnel does not have any salary or other information regarding the position.

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