Clinical Data Manager - Hybrid

Placements24; Pretoria; Hybride; ZAR 800 000 - 1 000 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement fund

Paid time off

Résumé du poste

Placements24 is seeking a Clinical Data Manager to join a growing pharmaceutical research organization in Pretoria, Gauteng, ZA. This hybrid role blends remote work flexibility with in-office collaboration to manage complex clinical trial data and ensure regulatory-grade quality.

You will oversee CDMPs, EDC systems like Medidata Rave, Inform, and Veeva, perform data cleaning, and coordinate with Biostatistics and Programming teams to support database lock and analyses.

Qualifications

• Bachelor's degree in a scientific/healthcare field.
• Minimum 4 years in clinical data management within pharma/biotech/CRO.
• Proficiency in EDC systems such as Medidata Rave, Inform, and Veeva.
• Knowledge of ICH-GCP and data privacy regulations.
• Strong analytical, problem-solving, and attention to detail.
• Excellent written and verbal communication.
• Ability to work in a hybrid Pretoria-based role.

Responsabilités

• Develop and maintain CDMPs in line with study protocols and regulatory requirements.
• Oversee design and validation of EDC systems and databases.
• Manage data cleaning, query tracking, and resolution with study teams.
• Ensure compliance with ICH-GCP and POPIA and internal SOPs.
• Perform data review and quality checks for accuracy and completeness.
• Collaborate with Biostatistics and Programming to enable timely database lock.
• Validate data management tools and systems.
• Train and mentor junior data management staff.
• Contribute to continuous improvement of data management processes.

Connaissances

Analytical thinking

Attention to detail

Communication skills

Formation

Bachelor's degree in a related field

Outils

Medidata Rave

Inform

Veeva

Description du poste

About the Role

Our client, a growing pharmaceutical research organization, is seeking a talented Clinical Data Manager to join their team in **Pretoria, Gauteng, ZA**. This hybrid role combines the benefits of remote work flexibility with essential in-office collaboration, fostering a productive and engaging work environment. The Clinical Data Manager will be responsible for the planning, execution, and oversight of clinical data management activities for complex clinical trials. You will ensure the accuracy, completeness, and integrity of clinical trial data, which is crucial for regulatory submissions and scientific analysis. This role is fundamental to the success of our client's drug development pipeline, requiring meticulous attention to detail and a strong understanding of data management principles.

Key Responsibilities

• Develop and maintain Clinical Data Management Plans (CDMPs) in accordance with study protocols and regulatory requirements.
• Oversee the design and validation of Electronic Data Capture (EDC) systems and databases.
• Manage data cleaning activities, including query generation, tracking, and resolution, in collaboration with clinical study teams and investigators.
• Ensure compliance with ICH-GCP guidelines, data privacy regulations (e.g., POPIA), and internal SOPs.
• Perform data review and quality checks to ensure data accuracy, consistency, and completeness.
• Collaborate with Biostatistics and Programming teams to facilitate timely database lock and data analysis.
• Participate in the validation of data management tools and systems.
• Train and mentor junior data management personnel as needed.
• Contribute to the continuous improvement of data management processes and standards.

Requirements

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• A minimum of 4 years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
• Proficiency in EDC systems (e.g., Medidata Rave, Inform, Veeva) and data management software.
• Solid understanding of clinical trial processes, database design, data validation, and data cleaning techniques.
• Knowledge of ICH-GCP guidelines and relevant data privacy regulations.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent written and verbal communication skills.
• Ability to work effectively both independently and as part of a hybrid team in **Pretoria, Gauteng, ZA**.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health insurance, retirement fund contributions, and paid time off. This hybrid position provides a flexible work arrangement, allowing for a healthy work-life balance. You will have the opportunity to work on exciting and cutting-edge clinical research projects. Professional development and training opportunities will be provided to support your career advancement. Join a collaborative and innovative environment where your skills in data management are highly valued, contributing to the advancement of healthcare from **Pretoria, Gauteng, ZA**.