Clinical Data Manager - Pharmaceutical Trials

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Hybrid work

Medical insurance

Growth opportunities

Life-saving research

Job summary

Placements24 in South Africa is seeking an experienced Clinical Data Manager to join our team in Nelspruit, operating under a hybrid work model. This role oversees data collection, validation and management across clinical trials, working with operations, biostatistics and programming to ensure data quality for regulatory submissions.

The ideal candidate has a Bachelor's degree and at least four years' experience with EDC systems like Medidata Rave or Oracle Clinical, CDISC standards, and strong

Qualifications

• Bachelor's degree in a relevant field such as Computer Science, Statistics, Life Sciences, or Health Informatics.
• Minimum of 4 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proficiency with various EDC systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes, data standards (e.g., CDISC), and regulatory requirements.
• Excellent analytical, problem-solving, and organizational skills.
• Effective communication and collaboration skills for working in a hybrid environment.

Responsibilities

• Develop and implement data management plans (DMPs) for clinical trials.
• Design, build, and test clinical databases using Electronic Data Capture (EDC) systems.
• Oversee data entry, validation, cleaning, and query resolution processes.
• Ensure compliance with ICH GCP guidelines and all applicable regulatory requirements.
• Collaborate with statisticians and programmers to prepare datasets for analysis.
• Manage data archival and retrieval processes post-study.

Skills

Analytical skills

Problem solving

Organizational skills

Communication skills

Team collaboration

Education

Bachelor's degree in Computer Science, Statistics, Life Sciences, or Health Informatics

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role

Our client is seeking an experienced Clinical Data Manager to join their team in Nelspruit , operating under a hybrid work model. This critical role involves overseeing the collection, validation, and management of clinical trial data to ensure its accuracy, completeness, and integrity. You will work closely with clinical operations, biostatistics, and programming teams to develop data management plans, design databases, and oversee data cleaning activities. The successful candidate will be instrumental in ensuring that the data generated from our pharmaceutical trials is reliable and suitable for regulatory submissions and scientific analysis.

Key Responsibilities

• Develop and implement data management plans (DMPs) for clinical trials.
• Design, build, and test clinical databases using Electronic Data Capture (EDC) systems.
• Oversee data entry, validation, cleaning, and query resolution processes.
• Ensure compliance with ICH GCP guidelines and all applicable regulatory requirements.
• Collaborate with statisticians and programmers to prepare datasets for analysis.
• Manage data archival and retrieval processes post-study.

Requirements

• Bachelor's degree in a relevant field such as Computer Science, Statistics, Life Sciences, or Health Informatics.
• Minimum of 4 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proficiency with various EDC systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes, data standards (e.g., CDISC), and regulatory requirements.
• Excellent analytical, problem-solving, and organizational skills.
• Effective communication and collaboration skills for working in a hybrid environment.

Benefits

• Competitive salary and bonus structure.
• Hybrid work arrangement offering flexibility.
• Comprehensive medical, dental, and vision insurance plans.
• Opportunities for professional growth and development in data management.
• Dynamic work environment in Nelspruit contributing to life-saving research.