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

About the Role

Our client is a premier pharmaceutical research organization actively seeking a highly skilled and experienced Remote Clinical Data Manager to focus on Pharmacovigilance activities. This is a fully remote position, allowing you to contribute to critical safety monitoring from anywhere. You will be responsible for the end-to-end management of clinical trial data, ensuring data integrity, accuracy, and compliance with regulatory standards. Your expertise in data handling, database management, and safety reporting will be vital in safeguarding patient well-being and supporting drug development programs. This role is perfect for a detail-oriented professional who thrives in a remote setting and possesses a deep understanding of both clinical data management and the nuances of pharmacovigilance data. Work from home and make a significant impact on global health.

Key Responsibilities

• Oversee the 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, collaborating with clinical sites and study teams to ensure data accuracy.
• Implement data quality control procedures and ensure data integrity throughout the study lifecycle.
• Manage data transfers and reconciliation activities, including SAE reconciliation.
• Prepare and review data management documentation, such as CRFs, data validation specifications, and database lock documentation.
• Ensure compliance with relevant regulatory requirements (e.g., ICH GCP, FDA, EMA guidelines) and internal SOPs.
• Collaborate with statisticians, programmers, and safety scientists to ensure timely and accurate data analysis.
• Participate in the development and implementation of data management systems and tools.
• Train and mentor junior data management staff on best practices in clinical data management and pharmacovigilance.

Requirements

• Bachelor's degree in a scientific or healthcare-related field; Master's degree preferred.
• Minimum of 5 years of progressive experience in clinical data management, with at least 2 years specifically in pharmacovigilance or drug safety.
• Proficiency in clinical data management systems (CDMS) such as Medidata Rave, Oracle Clinical, or similar platforms.
• Strong understanding of clinical trial processes, ICH-GCP guidelines, and pharmacovigilance regulations.
• Experience with database design, data validation, and query management.
• Excellent analytical, problem-solving, and organizational skills.
• Proven ability to manage multiple projects simultaneously in a remote work environment.
• Exceptional written and verbal communication skills.
• Demonstrated ability to work independently and collaboratively with global teams.
• High level of accuracy and attention to detail in all data-related tasks.

Benefits

• Remote work flexibility, eliminating commute and offering work-life balance.
• Highly competitive salary package reflective of your remote expertise.
• Comprehensive health, dental, and vision insurance plans.
• Retirement savings plan with company contributions.
• Generous paid time off, including vacation, sick leave, and holidays.
• Opportunities for professional development, certifications, and attending industry conferences.
• Access to cutting-edge data management technologies and software.
• A supportive and collaborative virtual team environment.
• Career advancement opportunities within a growing global pharmaceutical company.
• Direct contribution to ensuring the safety of new medicines worldwide.