Clinical Data Manager - Pharmaceutical Trials

Placements24; South Africa; On-site; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Professional development opportunities

Diverse clinical trials exposure

Job summary

Placements24 in Queenstown, South Africa, seeks a meticulous Clinical Data Manager to join the clinical operations team. You will oversee data integrity from study start-up to database lock, collaborating with CRAs, biostatisticians, and medical monitors to ensure accuracy and regulatory compliance.

This role requires a Bachelor’s degree and at least four years’ experience in clinical data management in pharma or biotech, with strong EDC knowledge (Medidata Rave, Oracle Clinical) and attention

Qualifications

• Bachelor's degree in a relevant field such as Computer Science, Statistics, or Life Sciences.
• Minimum of 4 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes, GCP, and data management best practices.
• Excellent analytical, problem-solving, and communication skills.

Responsibilities

• Oversee the design and development of clinical databases, including CRFs and data validation checks.
• Manage data entry, cleaning, and query resolution processes to ensure data accuracy and completeness.
• Perform data validation and reconciliation activities according to study protocols and data management plans.
• Collaborate with biostatistics and programming teams for data analysis and reporting.
• Ensure compliance with ICH-GCP guidelines and other regulatory requirements throughout the data lifecycle.

Skills

Analytical skills

Problem-solving

Communication skills

Attention to detail

Education

Bachelor's degree in Computer Science/Statistics/Life Sciences

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role

Our client is seeking a meticulous and experienced Clinical Data Manager to join their clinical operations team based in Queenstown . In this role, you will be responsible for the management and integrity of clinical trial data from study start-up to database lock. You will work closely with clinical research associates, biostatisticians, and medical monitors to ensure that data is accurate, complete, and compliant with regulatory standards. This position is essential for supporting the successful execution of clinical trials that lead to the development of new life-saving therapies.

Key Responsibilities

• Oversee the design and development of clinical databases, including Case Report Forms (CRFs) and data validation checks.


• Manage data entry, cleaning, and query resolution processes to ensure data accuracy and completeness.


• Perform data validation and reconciliation activities according to study protocols and data management plans.


• Collaborate with biostatistics and programming teams for data analysis and reporting.


• Ensure compliance with ICH-GCP guidelines and other relevant regulatory requirements throughout the data lifecycle.

Requirements

• Bachelor's degree in a relevant field such as Computer Science, Statistics, or Life Sciences.


• Minimum of 4 years of experience in clinical data management within the pharmaceutical or biotechnology industry.


• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).


• Strong understanding of clinical trial processes, GCP , and data management best practices.


• Excellent analytical, problem-solving, and communication skills.

Benefits

• Competitive salary and comprehensive benefits package.


• Opportunity to work on diverse clinical trials in Queenstown .


• Access to advanced data management tools and technologies.


• Professional development and training opportunities.


• Be part of a team dedicated to advancing medical research and patient care.