Clinical Data Manager - Pharmaceutical Studies

Placements24; Klerksdorp; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Bonus incentives

Medical and dental insurance

Retirement savings plan

Generous annual leave

Training and development

Collaborative research environment

Impactful medicines

Job summary

Placements24 is seeking a detail-oriented Clinical Data Manager to join our pharmaceutical client in Soweto, Gauteng. You will oversee database design, data validation, query management, and data reconciliation to ensure data integrity for regulatory submissions.

The role requires hands-on experience with EDC systems (Medidata Rave, Oracle Clinical, Veeva EDC), strong knowledge of GCP, and the ability to collaborate with clinical teams, biostatisticians, and IT staff.

Qualifications

• Bachelor’s degree in a scientific, technical, or healthcare-related field.
• 3–5 years of experience in clinical data management in pharma/biotech/CRO.
• Proficiency with EDC systems (Medidata Rave, Oracle Clinical, Veeva EDC).
• Strong understanding of GCP, ICH guidelines, and regulatory processes.

Responsibilities

• Oversee design, development, and maintenance of clinical databases using EDC systems.
• Develop and execute data management plans and validation plans.
• Define data validation specs and implement edit checks for data quality.
• Manage data cleaning, queries with investigative sites, and data reconciliation.
• Coordinate database lock activities with study teams.
• Ensure compliance with regulatory requirements and SOPs.
• Maintain study-specific data management documentation and updates.

Skills

Data management

Regulatory awareness

Analytical skills

Communication

Teamwork

Problem-solving

Education

Bachelor's degree in a scientific/technical/healthcare field

Tools

Medidata Rave

Oracle Clinial

Veeva EDC

Job description

About the Role

Our client, a dynamic pharmaceutical company dedicated to advancing healthcare solutions, is seeking a detail-oriented Clinical Data Manager to join their team in Soweto, Gauteng . This role is essential for the accurate and efficient management of clinical trial data, ensuring its integrity, quality, and compliance with regulatory standards. You will be responsible for database design, data validation, query management, and data reconciliation, working closely with clinical research teams, biostatisticians, and IT personnel. The ideal candidate will possess a strong understanding of clinical data management principles, EDC systems, and GCP guidelines. This position offers an exciting opportunity to contribute to pivotal clinical research projects and play a key role in the development of new pharmaceutical products. You will ensure that all data collected is reliable, valid, and suitable for statistical analysis and regulatory submission. We are looking for a proactive and organized individual with excellent problem-solving skills and a commitment to data quality. Your meticulous approach will be crucial in maintaining the integrity of our client's clinical research data. This role provides a valuable opportunity for professional growth within a collaborative research environment.

Key Responsibilities

• Oversee the design, development, and maintenance of clinical databases using EDC systems (e.g., Medidata Rave, Oracle Clinical).


• Develop and execute data management plans (DMPs) and data validation plans (DVPs).


• Define data validation specifications and implement edit checks to ensure data accuracy and consistency.


• Manage data cleaning activities, including generating and resolving data queries with investigative sites.


• Perform data reconciliation with other study databases (e.g., safety databases, clinical supplies databases).


• Ensure compliance with all relevant regulatory requirements (GCP, FDA, EMA) and company SOPs.


• Coordinate database lock activities in collaboration with clinical, statistical, and programming teams.


• Develop and maintain study-specific data management documentation.


• Participate in study team meetings and provide updates on data management activities.


• Contribute to the continuous improvement of data management processes and systems.

Requirements

• Bachelor's degree in a scientific, technical, or healthcare-related field.


• Minimum of 3-5 years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.


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


• Strong understanding of clinical trial processes, data flow, and ICH-GCP guidelines.


• Experience in database design, UAT, data validation, and query management.


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


• Strong attention to detail and commitment to data quality.


• Effective communication and interpersonal skills.


• Ability to work independently and as part of a cross-functional team.


• Familiarity with medical coding dictionaries (MedDRA, WHODrug) is a plus.

Benefits

• Competitive salary based on experience and qualifications.


• Performance-based bonus incentives.


• Comprehensive medical and dental insurance coverage.


• Retirement savings plan.


• Generous annual leave allowance.


• Opportunities for training and professional development.


• Work in a collaborative and innovative research setting.


• Contribute to the development of life-changing medicines.