Clinical Data Manager

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health Insurance

Pension Plan

Paid Time Off

Professional Development

Job summary

Placements24 seeks an experienced Clinical Data Manager to oversee collection, cleaning, and management of clinical trial data in Nelspruit. You will ensure data integrity for regulatory submissions and analyses, leading database design, validation, review, and final database lock.

The role requires 5+ years in clinical data management, proficiency with Medidata Rave or Oracle Clinical, and strong knowledge of ICH-GCP compliance. A hybrid work setting and collaborative teams are offered.

Qualifications

• Bachelor’s degree in a relevant scientific or healthcare field.
• Minimum of 5 years of experience in clinical data management.
• Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP).
• Excellent analytical, problem-solving, and communication skills.

Responsibilities

• Develop and manage clinical databases, including CRFs and edit checks.
• Oversee data cleaning and validation, resolving data queries in a timely manner.
• Ensure compliance with data management best practices, ICH-GCP, and regulatory guidelines.
• Participate in design and review of study protocols and statistical analysis plans.
• Generate data management reports and metrics for study progress and data quality.
• Collaborate with statisticians and programmers to ensure data transfer and analysis.
• Contribute to development and maintenance of data management SOPs and quality standards.

Skills

Analytics

Communication

Regulatory Knowledge

Data Management Systems

ICH-GCP

Education

Bachelor’s degree in a relevant scientific or healthcare field

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role

Our client is seeking an experienced Clinical Data Manager to oversee the collection, cleaning, and management of clinical trial data in Nelspruit . This critical role ensures the integrity, accuracy, and completeness of data used for regulatory submissions and scientific analysis. You will lead data management activities throughout the trial lifecycle, from database design and validation to data review and final database lock. The ideal candidate possesses a strong understanding of clinical trial processes, data management systems, and relevant regulatory requirements, working collaboratively with statisticians, programmers, and clinical operations teams to ensure high-quality data outputs.

Key Responsibilities

• Develop and manage clinical databases, including Case Report Forms (CRFs) and edit checks.
• Oversee the data cleaning and validation process, resolving data queries in a timely manner.
• Ensure compliance with data management best practices, ICH-GCP, and regulatory guidelines.
• Participate in the design and review of clinical study protocols and statistical analysis plans.
• Generate data management reports and metrics for study progress and data quality.
• Collaborate with statisticians and programmers to ensure smooth data transfer and analysis.
• Contribute to the development and maintenance of data management SOPs and quality standards.

Requirements

• Bachelor's degree in a relevant scientific or healthcare field.
• Minimum of 5 years of experience in clinical data management .
• Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP).
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple projects simultaneously in a hybrid setting.

Benefits

• Competitive annual salary and performance-related bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan options.
• Paid time off and professional development opportunities.
• A dynamic and collaborative work environment in Nelspruit , focused on data integrity.