Clinical Data Manager

Placements24; South Africa; Remote; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary package

Health, dental, and vision insurance

Job summary

Placements24 is seeking a highly skilled Clinical Data Manager to join a fully remote data management team. This role ensures data integrity, accuracy, and reliability for diverse clinical trials, working with global experts from a home office.

The candidate will oversee database design, DM plans, data cleaning, and query resolution, while ensuring GDPR/HIPAA and GCP compliance. Collaboration with operations, biostatistics and programming teams is essential.

Qualifications

• Bachelor's degree or higher in a quantitative discipline.
• Minimum 5 years of clinical data management experience in pharma/CRO environments.
• Experience with data management systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault EDC).
• Strong knowledge of ICH-GCP, regulatory requirements and data privacy (GDPR/HIPAA).
• Excellent analytical, problem-solving and communication skills.

Responsibilities

• Develop, validate, and manage clinical databases per study protocols and DM plans.
• Oversee design/implementation of data collection tools (eCRFs).
• Lead data cleaning, generate/resolve queries.
• Perform quality checks to ensure data accuracy and completeness.
• Collaborate with clinical operations, biostatistics, and programming to achieve timely DB locks.
• Contribute to DM standards and SOPs.
• Ensure compliance with GDPR/HIPAA and GCP.

Skills

Clinical data management

Data cleaning

Remote collaboration

Query resolution

Analytical thinking

Education

Bachelor's degree in Statistics, Computer Science, Life Sciences, or related quantitative field

Tools

Medidata Rave

Oracle Clinical

Veeva Vault EDC

Job description

About the Role

Our client is seeking a highly skilled and experienced Clinical Data Manager to join their fully remote data management team. This role is pivotal in ensuring the integrity, accuracy, and reliability of clinical trial data, which is essential for evaluating drug safety and efficacy. You will oversee the design of databases, develop data management plans, and lead data cleaning activities to ensure high-quality datasets for analysis. This position offers the opportunity to work on diverse clinical trials, collaborate with a global team of experts, and contribute to groundbreaking pharmaceutical research from the comfort of your home office, fostering a culture of data excellence and scientific rigor.

Key Responsibilities

• Develop, validate, and manage clinical databases according to study protocols and data management plans.
• Oversee the design and implementation of data collection tools, including electronic Case Report Forms (eCRFs).
• Lead data cleaning activities, including query generation and resolution, to ensure data accuracy and completeness.
• Perform quality control checks on clinical data and datasets to identify and rectify discrepancies.
• Collaborate closely with clinical operations, biostatistics, and programming teams to ensure timely database lock.
• Contribute to the development and implementation of data management standards and Standard Operating Procedures (SOPs).
• Ensure compliance with data privacy regulations (e.g., GDPR, HIPAA) and Good Clinical Practice (GCP).

Requirements

• Bachelor's degree in Statistics, Computer Science, Life Sciences, or a related quantitative field.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proficiency in clinical data management systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault EDC).
• Strong understanding of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
• Excellent analytical, problem-solving, and organizational skills.
• Experience with database design, data validation, and query management.
• Effective communication and interpersonal skills for remote collaboration.

Benefits

• Competitive annual salary and performance bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous paid time off and flexible remote working arrangements.
• Retirement savings plan with employer contributions.
• Opportunities for professional development, training, and certifications.
• The chance to work with innovative technologies and contribute to critical pharmaceutical research globally.