Remote Clinical Data Manager

Placements24; Kimberley; Hybrid; CAD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

Professional development

Job summary

Placements24 is seeking an experienced Clinical Data Manager to lead data management across the lifecycle of clinical trials in a fully remote role. You will design databases, validate data, perform cleaning, and support database lock while ensuring data quality and regulatory compliance.

The ideal candidate has 5+ years in clinical data management, strong knowledge of CDISC standards (SDTM/ADaM), proficient with EDC systems (Medidata Rave, Oracle Clinical, Inform), and can work independently in

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum 5 years in clinical data management.
• Strong knowledge of CDISC SDTM/ADaM standards.
• Experience with EDC systems (Medidata Rave, Oracle Clinical, Inform).
• Excellent remote-working and communication skills.

Responsibilities

• Manage database build, edit checks, and data validation per protocol.
• Oversee data cleaning, query resolution, and timely task completion.
• Ensure GCP compliance and alignment with SOPs.
• Collaborate with operations, biostatistics, programming, and sites.
• Lead UAT and ensure database lock and archival.

Skills

Remote work capability

Data management

EDC systems

CDISC standards

Regulatory knowledge

Education

Bachelor's degree in life sciences

Tools

Medidata Rave

Oracle Clinical

Inform

Job description

About the Role

Our client is seeking a highly skilled and experienced Clinical Data Manager to join their growing team in a fully remote position. This role is crucial for the successful execution of clinical trials, ensuring the integrity, accuracy, and quality of data collected. You will oversee the entire data management lifecycle, from database design and build to data validation, cleaning, and database lock. The ideal candidate possesses a deep understanding of clinical trial processes, data standards (e.g., CDISC), and data management software, and excels in a remote work environment . This is an excellent opportunity to contribute to life-saving research within the pharmaceutical industry from anywhere in South Africa .

Key Responsibilities

• Manage the clinical database build, edit checks, and data validation process according to protocol requirements and data management plans.
• Oversee data cleaning activities, query resolution, and ensure the timely completion of data management tasks.
• Ensure compliance with Good Clinical Practice (GCP), relevant regulatory requirements, and company SOPs.
• Collaborate closely with clinical operations, biostatistics, programming, and site personnel to ensure data quality and consistency.
• Develop and maintain data management documentation, including data management plans (DMPs) and database specifications.
• Lead User Acceptance Testing (UAT) for clinical databases and ensure successful database lock and archival.

Requirements

• Bachelor's degree in a life science, computer science, statistics, or a related field.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotech industry.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Inform).
• Strong understanding of CDISC standards (SDTM, ADaM) and their implementation.
• Excellent understanding of clinical trial processes and regulatory requirements (GCP).
• Exceptional organizational skills, meticulous attention to detail, and the ability to work independently in a remote setting .

Benefits

• Competitive annual salary with bonus potential.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• Opportunities for professional development, including access to training and conferences.
• A flexible, remote work arrangement allowing for a great work-life balance within the pharmaceutical research sector.