Remote Clinical Data Manager

Placements24; LegKraal Gate; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Remote-first culture

Job summary

Placements24 is seeking a highly organized Remote Clinical Data Manager to join a growing pharmaceutical company. This fully remote role focuses on designing clinical databases, data validation, and ensuring data integrity across therapeutic areas, with collaboration across statisticians and investigators.

You will work independently in a virtual environment and ensure compliance with GCP and data privacy regulations.

Qualifications

• Bachelor's degree in life science, computer science, statistics, or related field.
• Minimum of 4 years of experience as a Clinical Data Manager in the pharmaceutical, biotechnology, or CRO industry.
• Proficiency with at least one major Clinical Data Management System (CDMS), such as Medidata Rave, Oracle Clinical, or similar.
• Solid understanding of clinical trial processes, GCP, and data management best practices.
• Experience in database design, data validation, and query management.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Excellent communication and interpersonal skills, crucial for remote collaboration.
• Ability to work independently, manage multiple projects, and meet strict deadlines.
• Familiarity with EDC systems and data standards (e.g., CDISC SDTM).
• Proficiency in English is essential.

Responsibilities

• Design, develop, and maintain clinical databases in accordance with study protocols and regulatory requirements.
• Develop and execute data validation plans, performing data cleaning and query management.
• Ensure data accuracy, completeness, and consistency across all clinical studies.
• Collaborate with clinical operations, biostatistics, and programming teams to define data management requirements.
• Develop and review Case Report Forms (CRFs) and other study-related documentation.
• Manage the import of external data (e.g., central lab data, imaging data) into the clinical database.
• Generate data management reports and metrics to track study progress and data quality.
• Ensure compliance with Good Clinical Practice (GCP) and relevant data privacy regulations (e.g., GDPR, POPIA).
• Participate in the qualification and validation of Clinical Data Management Systems (CDMS).
• Contribute to the continuous improvement of data management processes and standards.

Skills

Analytical skills

Attention to detail

Communication

Remote collaboration

Education

Bachelor's degree in life science, computer science, statistics, or related field

Tools

Medidata Rave

Oracle Clinical

CDMS

Job description

About the Role

Our client, a rapidly growing global pharmaceutical company, is seeking a highly organized and detail-oriented Remote Clinical Data Manager to join their dynamic team. This is a fully remote position, allowing you to work from anywhere while playing a pivotal role in managing and ensuring the quality of clinical trial data. You will be responsible for designing clinical databases, managing data entry, performing data validation, and ensuring data integrity for clinical studies conducted across various therapeutic areas. This role demands exceptional organizational skills, a strong understanding of data management principles, and the ability to work independently in a virtual environment. You will collaborate closely with biostatisticians, clinical research associates, and investigators to ensure accurate and timely data delivery. Our client is committed to a remote-first culture, providing robust tools and support for seamless virtual collaboration. This position offers a fantastic opportunity to contribute to life-saving research from the convenience of your home office, leveraging cutting-edge technology and processes. Your work will directly influence the success of critical drug development programs. The role requires a proactive approach and a keen eye for detail in managing complex datasets.

Key Responsibilities

• Design, develop, and maintain clinical databases in accordance with study protocols and regulatory requirements.
• Develop and execute data validation plans, performing data cleaning and query management.
• Ensure data accuracy, completeness, and consistency across all clinical studies.
• Collaborate with clinical operations, biostatistics, and programming teams to define data management requirements.
• Develop and review Case Report Forms (CRFs) and other study-related documentation.
• Manage the import of external data (e.g., central lab data, imaging data) into the clinical database.
• Generate data management reports and metrics to track study progress and data quality.
• Ensure compliance with Good Clinical Practice (GCP) and relevant data privacy regulations (e.g., GDPR, POPIA).
• Participate in the qualification and validation of Clinical Data Management Systems (CDMS).
• Contribute to the continuous improvement of data management processes and standards.

Requirements

• Bachelor's degree in a life science, computer science, statistics, or related field.
• Minimum of 4 years of experience as a Clinical Data Manager in the pharmaceutical, biotechnology, or CRO industry.
• Proficiency with at least one major Clinical Data Management System (CDMS), such as Medidata Rave, Oracle Clinical, or similar.
• Solid understanding of clinical trial processes, GCP, and data management best practices.
• Experience in database design, data validation, and query management.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Excellent communication and interpersonal skills, crucial for remote collaboration.
• Ability to work independently, manage multiple projects, and meet strict deadlines.
• Familiarity with EDC systems and data standards (e.g., CDISC SDTM).
• Proficiency in English is essential.

Benefits

This remote position offers a competitive salary, comprehensive health insurance, and retirement savings options. Our client provides extensive opportunities for professional development, including training on new technologies and methodologies. A flexible work environment allows for excellent work-life balance. Paid time off includes generous vacation, sick leave, and holidays. The company fosters a culture of innovation and collaboration, supporting employees in their career growth. Being a remote role, the geographical location is flexible, with the company based nationally and this role ideally suited for individuals residing anywhere in South Africa, aligning with the spirit of Mahikeng's position as a provincial capital, signifying connection and access.