Main purpose of the job:
- To adhere to processes and procedures that are in place in order to develop and manage clinical trial study databases and to produce high-quality study data
- Staff management
- PHRU, Chris Hani Baragwanath New Nurses Home, Soweto – Johannesburg
Key performance areas:
- Meet relevant stakeholders to ensure planning and data requirements at the start of a study or as needed
- Determine protocol specifications in line with the project
- Determine database type in line with customer need
- Design Case Report Forms (CRF) according to the protocol (project-specific) and study file (user manual compilation)
- Testing and making sure that the Database is correctly set up
- Ensure the study setup is done correctly by performing variable validation
- Develop Data Quality Management Plan according to the relevant template
- Design a database to ensure patient follow up schedules are adhered to
- Identify users and grant access accordingly before the start of the study, and as and when required
- Train users on the new database at the start of the study, or as and when required
- Ensure that training registers and CRF completion guidelines are signed off and submitted as per the relevant SOPs
- Ensure correct live implementation of the study database after the study setup validation has been completed
- Document all the necessary processes and procedures, as per the relevant Data Management SOPs
- Ensure that the Data Management Study File is completed and maintained as per the relevant Data Management SOPs
- Monitor issues that arise which may require additional staff training, CRF amendments
- Maintain database Specifications Document, which records changes made to variables, as and when required
- Accurately complete Database Structural Change Logs, which document structural changes to the database
- Test/Document all database variable/structural changes
- Perform/Monitor data quality assurance processes, as outlined in the study Data Quality Management Plan
- Perform/Monitor data quality control processes
- Ensure corrective action is implemented in terms of the code of conduct and in consultation with Data
- Operations Manager and/or HR department
- Ensure efficient manpower planning on a daily basis
- Ensure training and development of staff occurs as and when needed
- Perform and facilitate performance development and assessments
- Ensure leave management in compliance with company policy and procedure
- Take ownership and accountability for tasks & activities and demonstrates effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Inform relevant parties in the event of tasks or deadlines not met and provide appropriate means of resolution
- Support and drives the business’ core values
- Maintain a positive attitude
- Respond openly to feedback
- Take ownership of your own career development
- Develop excellent staff management skills
- Manage colleagues’ and client’s expectations, and communicate appropriately
- Willing to help others and go the extra mile to meet team/department targets and objectives
Required minimum education and training:
- Grade 12
- Current Good Clinical Practice certificate
- Computer literate (Microsoft Outlook, Word, and Excel)
- Technical Diploma related to database development and management, SAS training/certification
- MS Office at an advanced level
Required minimum work experience:
- 5 years of clinical data management experience in a related position
Desirable additional education, work experience, and personal abilities:
- SQL Knowledge
- Project Management
- Staff Management
- Ability to work independently and within a team
- Conflict Management; Professionalism
- Customer Centricity and ability to delegate and follow up
- Excellent communication skills
- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- Please Apply Online and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate 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.
- AJ Personnel is fully POPIA Compliant.
- 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: 06 April 2022.
- 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.
- 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: Our Client, WHC – PHRU, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.
- AJ Personnel is only responsible for advertising the advertisement on behalf of their client Wits Health Consortium.
- AJ Personnel does not have any salary or other information regarding the position.
About The Employer:
The Perinatal HIV Research Unit (Wits PHRU) was established in 1996. The Perinatal HIV Research Unit has been involved in research, training, policy formation, and advocacy on issues concerning HIV-positive women and their children.
In recent years the work of the unit has expanded beyond the original focus of mother-to-child transmission of HIV.