Data Manager in Clinical Trials

ATS Client; Pretoria; On-site; ZAR 550,000 - 850,000; Full time

Job summary

ATS Client in Pretoria is seeking a Clinical Data Manager to oversee data collection, validation and QC across clinical studies. You will design eCRF layouts, DMPs and test EDC databases, ensuring accurate data capture and timely archiving.

Strong English skills and experience with major CDM systems are essential. The role requires coordinating with clients, project teams and vendors, training site staff, and maintaining data management files.

Qualifications

• College/University degree (Life Science, Pharmacy degree is a plus)
• Demonstrated experience of managing clinical or medical data
• Full working proficiency in English
• Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)
• Proficiency in MS Office applications
• Organisational and time management skills
• Ability to work independently and multi-task

Responsibilities

• Track database set-up, testing, maintenance and data entry
• Communicate with clients, project teams and vendors on data management matters
• Review study documents, design and develop project specific guidelines and instructions
• Design eCRF, Data Management and Data Validation Plans and test EDC databases
• Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
• Code medical data
• Track and report metrics leading to database lock
• Coordinate the processing, dispatch and archiving of CRFs/queries
• Maintain Clinical Data Management working files
• Perform database QC checks, prepare and attend audits
• Train site staff and project teams on CRF completion and data management topics

Skills

English Proficiency

MS Office proficiency

Organizational and time management

Independent working

Multi-tasking

Education

Life Science degree

Pharmacy degree (nice to have)

Tools

Medidata Rave

Oracle InForm

Job description

Job Description

Clincial Data Manager plays a critical role in the clinical research project. If you are detail-oriented and committed to quality, able to work with large volume of clinical or medical data, you might be the professional we are looking for.

Location

Full-time employment in Pretoria, South Africa

Responsibilities

• Track database set-up, testing, maintenance and data entry
• Communicate with clients, project teams and vendors on data management matters
• Review study documents, design and develop project specific guidelines and instructions
• Design eCRF, Data Management and Data Validation Plans and test EDC databases
• Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
• Code medical data
• Track and report metrics leading to database lock
• Coordinate the processing, dispatch and archiving of CRFs/queries
• Maintain Clinical Data Management working files
• Perform database QC checks, prepare and attend audits
• Train site staff and project teams on CRF completion and data management topics

Qualifications

• College/University degree (Life Science, Pharmacy degree is a plus)
• Demonstrated experience of managing clinical or medical data
• Full working proficiency in English
• Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)
• Proficiency in MS Office applications
• Organisational and time management skills
• Ability to work independently and multi-task