Clinical Data Manager

Placements24; Queenstown; Hybrid; NZD 90,000 - 150,000; Full time

Benefits offered by this job

Fully remote work arrangement

Home office support

Professional growth

Job summary

Placements24 is seeking a detail-oriented Clinical Data Manager to join our fully remote clinical operations team. You will design, develop, and maintain clinical databases, oversee data collection, validation, and cleaning processes, and ensure data quality and regulatory compliance from a remote setting.

Ideal candidates hold a bachelor's degree, at least 4 years in clinical data management within pharma or CRO environments, strong experience with EDC systems (Medidata Rave, Oracle Clinical)

Qualifications

• Bachelor's degree in a scientific or technical field.
• 4+ years of clinical data management experience in pharma or CRO.
• Experience with EDC systems (Medidata Rave, Oracle Clinical).
• Strong understanding of CDISC SDTM/ADaM standards.
• Knowledge of data privacy regulations and GCP.

Responsibilities

• Design clinical database specifications, including data standards, edit checks, and user requirements.
• Oversee the setup, testing, and validation of clinical databases using EDC systems.
• Develop and implement data management plans (DMPs) to guide data collection and quality.
• Manage the data cleaning process, including query generation, resolution, and reconciliation.
• Ensure compliance with data privacy regulations (e.g., POPIA) and Good Clinical Practice (GCP).
• Collaborate with biostatisticians, clinical programmers, and clinical research associates to ensure data accuracy.

Skills

EDC systems

CDISC (SDTM/ADaM)

GCP compliance

Data management

Remote work organization

Education

Bachelor's degree in relevant field

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role

Our client is looking for a detail-oriented and experienced Clinical Data Manager to join their fully remote clinical operations team. This position is vital for ensuring the integrity, quality, and timeliness of clinical trial data. You will be responsible for the design, development, and maintenance of clinical databases, as well as overseeing data collection, validation, and cleaning processes. The ideal candidate possesses a strong understanding of data management principles, clinical trial processes, and regulatory requirements, enabling them to contribute effectively to the successful execution of critical research studies from a remote work setting.

Key Responsibilities

• Design clinical database specifications, including data standards, edit checks, and user requirements.
• Oversee the setup, testing, and validation of clinical databases using EDC systems.
• Develop and implement data management plans (DMPs) to guide data collection and quality.
• Manage the data cleaning process, including query generation, resolution, and reconciliation.
• Ensure compliance with data privacy regulations (e.g., POPIA) and Good Clinical Practice (GCP).
• Collaborate with biostatisticians, clinical programmers, and clinical research associates to ensure data accuracy.

Requirements

• Bachelor's degree in a relevant scientific or technical field.
• Minimum of 4 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of CDISC standards (SDTM, ADaM).
• Excellent knowledge of clinical trial processes and regulatory requirements.
• Exceptional organizational, analytical, and problem-solving skills for remote work.

Benefits

• Competitive annual salary and performance-based incentives.
• Fully remote work arrangement with home office support.
• Comprehensive health, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Opportunities for professional growth and skill development.