Clinical Data Manager

Placements24; Soweto; Hybrid; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, vision insurance

Retirement plan with employer match

Hybrid work in Soweto

Professional development

Job summary

Placements24 is seeking a skilled Clinical Data Manager to join our clinical operations team in Soweto, offering a hybrid work structure. You will ensure data integrity, design databases, and oversee data collection, cleaning, and database lock to support reliable trial outcomes.

A Bachelor’s degree in life sciences or related field and at least four years of data management experience are required, with hands-on use of EDC systems (Medidata Rave, Oracle Clinical).

Qualifications

• Bachelor’s degree in life science or related field.
• Minimum of four years of experience in clinical data management.
• Proficiency with CDM systems (e.g., EDC like Medidata Rave, Oracle Clinical).
• Strong understanding of GCP and CDISC data standards.

Responsibilities

• Develop and implement clinical data management plans and SOPs.
• Design study databases including CRFs, edit checks, and data validation specs.
• Oversee data collection, query management, and data cleaning for accuracy.
• Perform data analysis and reporting to support milestones and database lock.
• Ensure compliance with GCP and regulatory requirements (FDA, EMA).
• Collaborate with CRCs, biostatisticians, and investigators to ensure high-quality data.

Skills

Analytical skills

Problem-solving

Communication

Education

Bachelor's degree in life sciences or related field

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role

Our client is seeking a skilled and organized Clinical Data Manager to join their growing clinical operations team serving the Soweto area. This role is integral to the successful execution of clinical trials, ensuring the integrity, accuracy, and completeness of clinical data collected. You will be responsible for the design of databases, development of data management plans, and oversight of data collection, cleaning, and database lock processes. This position offers a crucial role in supporting the development of new therapies, contributing to reliable research outcomes within a hybrid work structure.

Key Responsibilities

• Develop and implement clinical data management plans and standard operating procedures (SOPs).
• Design study databases, including case report forms (CRFs), edit checks, and data validation specifications.
• Oversee data collection, query management, and data cleaning processes to ensure data accuracy and consistency.
• Perform data analysis and reporting to support study milestones and database lock.
• Ensure compliance with Good Clinical Practice (GCP) and relevant regulatory requirements (e.g., FDA, EMA).
• Collaborate with clinical research associates, biostatisticians, and investigators to ensure high-quality data.

Requirements

• Bachelor's degree in a life science, computer science, statistics, or a related field.
• Minimum of 4 years of experience in clinical data management.
• Proficiency with clinical data management systems (e.g., EDC systems like Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes, GCP, and data standards (e.g., CDISC).
• Excellent analytical and problem-solving skills, with meticulous attention to detail.
• Effective communication and interpersonal skills, with the ability to work collaboratively.

Benefits

• Competitive annual salary and performance incentives.
• Comprehensive medical, dental, and vision insurance.
• Retirement savings plan with employer match.
• Opportunities for professional development and training in data management technologies.
• A supportive team environment offering hybrid work flexibility in Soweto .