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.
