Main purpose of the job: Provide overall management of clinical trials or clinical programs within Wits DIH Location: WDIH - Sunnyside Office Park, 32 Princess of Wales Terrace, Parktown - Johannesburg Key performance areas: Review project protocols and gain understanding of the scope of laboratory requirements Drafting of Quote as per protocol requirements Drafting of 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 Assist with services agreements if required for sponsor Drafting of request forms and other study related documents Ensure project and protocol amendments are implemented as required All study projects are set up according to Good Clinical Laboratory Practice (GCLP), Good Clinical Practice (GCP) 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 status and other administrative reports and submit to sponsors and other internal stakeholders as required by the contract Report timeously on project progress, the results of risk analyses, contingency plans, technical information, and input from team throughout the project Conduct site staff training as appropriate Process validation: All dry run documents must be completed and reviewed by all CLS departments Errors noted during dry run process must be addressed and corrected before 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 in Medical Technology or BSC in Health Sciences or relevant work experience Required minimum work experience: 5 years' experience in a Medical Laboratory 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 Financial and budgeting understanding Must be able to multitask, assertive and customer orientated Ability to operate in a pressurized environment Excellent MS Office Skills Good Interpersonal and communication skills with both internal and external stakeholders TO APPLY: Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV. Please Apply Online. Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position. The closing date for all applications: 10 July 2024. Note AJ Personnel is fully POPI compliant. Note WHC, in accordance with their 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. Please note: AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium. 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. AJ Personnel does not have any salary or other information regarding the position.
