Remote Clinical Data Manager - Pharmacovigilance

Placements24; Rustenburg; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Remote work

Competitive salary

Health insurance

Retirement plan

Paid time off

Professional development

Job summary

Placements24 invites an experienced Remote Clinical Data Manager to focus on pharmacovigilance activities within a premier pharmaceutical environment. You will manage end-to-end clinical trial data, ensure data integrity, and comply with ICH GCP and regulatory expectations while working remotely with global teams.

The role emphasizes data handling, CDMS expertise (Medidata Rave, Oracle Clinical), data quality control, SAE reconciliation, and mentoring junior staff.

Qualifications

• 5+ years of progressive clinical data management experience.
• Minimum 2+ years in pharmacovigilance or drug safety.
• Proficiency with CDMS and data validation processes.
• Strong knowledge of ICH-GCP and regulatory guidelines.

Responsibilities

• Oversee collection, validation, cleaning, and management of clinical trial data for pharmacovigilance studies.
• Develop and maintain clinical databases, ensuring adherence to data management plans and protocols.
• Perform data query generation and resolution with sites and study teams.
• Implement data quality control procedures and maintain data integrity throughout the lifecycle.
• Manage data transfers and SAE reconciliation and documentation.
• Prepare and review data management documentation (CRFs, specs, database lock).
• Ensure regulatory compliance (ICH GCP, FDA, EMA) and SOP adherence.
• Collaborate with statisticians, programmers, and safety scientists for timely analyses.
• Train and mentor junior data management staff on best practices.

Skills

CDMS

Data quality

Pharmacovigilance

Regulatory knowledge

Education

Bachelor's degree

Master's degree preferred

Tools

Medidata Rave

Oracle Clinical

Job description

Placements24 invites an experienced Remote Clinical Data Manager to focus on pharmacovigilance activities within a premier pharmaceutical environment. You will manage end-to-end clinical trial data, ensure data integrity, and comply with ICH GCP and regulatory expectations while working remotely with global teams.

The role emphasizes data handling, CDMS expertise (Medidata Rave, Oracle Clinical), data quality control, SAE reconciliation, and mentoring junior staff.