Data Manager

2 weeks ago

Johannesburg, South Africa AJ Personnel Full time

**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.

**Location**:
PHRU, Chris Hani Baragwanath New Nurses Home, Soweto

**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 project.
- Determine database type in line with customer need.
- Design Case Report Forms (CRF) according to protocol (project specific) and study file (user manual compilation).
- Testing and making sure that 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 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 data base 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 set up 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 for 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.
- Manage own disruptive emotions (handle stress in ways that do not negatively impact on the team).
- Inspire subordinates by always setting a good example.

**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**:

- **Five years clinical data management experience in a related position.**

**Desirable additional education, work experience and personal abilities**:

- Programming.
- DF Explore.
- SAS experience.
- SQL Knowledge.
- Project Management.
- Staff Management.
- Diligence.
- Ability to work independently and within a team.
- Conflict Management.
- Professionalism.
- Customer Centricity and ability to delegate and follow up.
- Excellent communication skills.

**TO APPLY**:

- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- 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.**:

- **The organisation maintains a Mandatory Covid-19 requirement and as such only Covid-19 Vaccinated incumbents will be considered for positions.**

**Please note**:

- **AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.**:

- **AJ Personnel does not have any salary or other information regarding the position.

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