Clinical Operations & Governance Coordinator

Higher Health; Pretoria; On-site; ZAR 420,000 - 600,000; Full time

Job summary

Higher Health in Pretoria is seeking a Clinical Operations Governance Coordinator to manage end-to-end data management services for single or multi-service projects. You will ensure quality deliverables, lead the Data Management team, and oversee planning, execution, and close-out with a focus on sponsor satisfaction.

The role requires a health/science degree and 3–4 years in data management, including CDM lead experience, with strong English and advanced MS Office skills.

Qualifications

• Bachelor’s degree in health, clinical, biological or mathematical sciences with proven data management experience.
• 3–4 years direct Data Management experience, including 1 year as a CDM lead.
• English fluency (spoken) and advanced English
• Advanced computer applications like Microsoft Excel, Word, Inbox, etc.

Responsibilities

• Gather study setup requirements through discussions with stakeholders.
• Oversee validation of new device integrations with minimal guidance.
• Conduct data cleaning to ensure quality and timely deliverables for sponsors.
• Ensure deliverables meet quality standards and contracted timelines.
• Lead internal study meetings and sponsor audits; participate in kick-off meetings.
• Monitor project progress, identify risks, and implement corrective actions.

Skills

Data management

Project leadership

Communication

Quality assurance

SOP adherence

Education

Bachelor's degree in health/science

Tools

Microsoft Excel

MS Word

Clinical data systems

Job description

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Centurion, South Africa
Full time
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Job Overview
Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL).
Essential Functions
- Gather Study Set up requirements through discussion and communication with relevant stakeholders.
- With Minimal guidance - support, overview of validation of new Device integrations.
- Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
- Ensure that all the deliverables are of expected quality standards and meet customer expectations.
- With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
- Support Training of New joiners.
- Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
- Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
- With Guidance manage & oversight the implementation of new technology / database revisions.
- Work closely with the programming team for process innovation and automation.
- Be compliant to trainings and eSOP reading.
- Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
- Communication with Line Manager, and other team members across functions should be collaborative.
- Perform other duties as directed by Line Manager.
Qualifications
- Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req
- 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
- English Fluency Spoken and English Advanced
- Advanced computer applications like Microsoft excel, word, Inbox etc Advanced
- Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced