Senior Clinical Data Manager

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

Benefits offered by this job

Health insurance

Retirement savings contributions

Paid time off

Professional development opportunities

Hybrid work model

Job summary

Placements24 is actively seeking a Senior Clinical Data Manager to support operations in Kimberley, Northern Cape. The role focuses on ensuring data accuracy, completeness, and integrity across clinical trials, with oversight of database design, validation, and cleaning.

You will work in a hybrid setup, collaborating with clinical operations, biostatistics, and programming teams to ensure regulatory adherence and high data quality for successful studies.

Qualifications

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 5 years' experience in clinical data management.
• Experience with EDC systems (Medidata Rave, Oracle Clinical).
• Strong knowledge of ICH-GCP and data management best practices.
• Strong analytical, organizational, and communication skills.

Responsibilities

• Oversee design, development, and validation of clinical databases using EDC.
• Develop data management plans and validation specifications.
• Lead data cleaning, including query generation and resolution.
• Ensure data quality across multiple studies.
• Collaborate with biostatistics and programming teams for analyses.
• Perform UAT for database builds and changes.
• Provide mentorship to junior data management staff.
• Ensure GCP/compliance with regulatory standards.

Skills

EDC systems

Data cleaning

Analytical thinking

Communication

Team mentorship

Education

Bachelor's degree in scientific/technical/healthcare field

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role

Our client, a leading Contract Research Organization (CRO), is seeking an experienced Senior Clinical Data Manager to join their team supporting operations in Kimberley, Northern Cape, ZA. This hybrid role is crucial for ensuring the accuracy, completeness, and integrity of clinical trial data, which underpins the safety and efficacy of new pharmaceutical products. You will oversee the database design, data validation, and data cleaning processes, collaborating closely with clinical operations, biostatistics, and programming teams. The hybrid nature of this role allows for focused work on-site and flexible remote data analysis and team collaboration. Your expertise will be vital in managing complex datasets and ensuring compliance with regulatory standards, contributing directly to the successful completion of clinical studies.

Key Responsibilities

• Oversee the design, development, and validation of clinical databases using EDC systems.
• Develop and implement data management plans (DMPs) and data validation specifications.
• Manage data cleaning activities, including query generation and resolution.
• Ensure data consistency, accuracy, and completeness across multiple studies.
• Collaborate with biostatisticians and programmers to ensure data are suitable for statistical analysis.
• Perform User Acceptance Testing (UAT) for database builds and modifications.
• Provide guidance and mentorship to junior data management staff.
• Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and company SOPs.

Requirements

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 5 years of experience in clinical data management.
• Proven experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes, ICH-GCP guidelines, and data management best practices.
• Experience in database design, data validation, and data cleaning.
• Excellent analytical and problem-solving skills.
• Strong organizational skills with meticulous attention to detail.
• Effective communication and interpersonal skills, suitable for hybrid collaboration.
• Ability to manage multiple tasks and prioritize effectively.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including health insurance, retirement savings contributions, and paid time off.
• Professional development opportunities, including training and conference attendance, are provided.
• The hybrid work model supports a healthy work-life balance.
• Employees have access to state-of-the-art technology and a collaborative work environment focused on quality and efficiency in clinical data management.