Senior Pharmaceutical Data Manager

Placements24; Sandton; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Pension fund

Medical aid

Professional growth opportunities

Job summary

Placements24 is seeking a Senior Pharmaceutical Data Manager to join our clinical data management team in Sandton. You will oversee database design, data validation, and ensure compliance with regulatory standards across trials.

You will collaborate with statisticians and operations, manage multiple data projects, and drive timely database locks while upholding CDISC SDTM/ADaM guidelines and industry best practices.

Qualifications

• Bachelor’s degree in Computer Science, Statistics, Life Sciences, or related field.
• Minimum 5 years of experience in clinical data management in pharma/biotech.
• Experience with EDC systems and regulatory data standards.

Responsibilities

• Oversee design, build, and testing of clinical databases using EDC systems.
• Develop data validation specs, review data, and resolve discrepancies.
• Manage data cleaning and timely database locks per timelines.
• Provide guidance to the data management team and sites.
• Ensure compliance with FDA/EMA/SAHPRA and CDISC standards.
• Collaborate with statisticians and operations to meet data needs.
• Contribute to SOPs and data management processes.

Skills

Attention to detail

Analytical thinking

Communication skills

Team collaboration

Education

Bachelor's degree in Computer Science, Statistics, Life Sciences, or a related field

Tools

Medidata Rave

Oracle InForm

CDISC SDTM

CDISC ADaM

Job description

About the Role

Our client is seeking a detail-oriented and highly skilled Senior Pharmaceutical Data Manager to join their clinical data management team in Sandton . This role is integral to ensuring the accuracy, integrity, and timeliness of clinical trial data collected during drug development. You will be responsible for database design, data validation, and ensuring compliance with data management standards and regulatory requirements. This position offers a fantastic opportunity for a data management professional to work on impactful clinical trials and contribute to the development of innovative medicines within a supportive team environment.

Key Responsibilities

• Oversee the design, build, and testing of clinical databases using EDC systems, ensuring compliance with study protocols and data management plans.
• Develop and implement data validation specifications, conduct data review, and resolve data discrepancies efficiently.
• Manage data cleaning activities and ensure timely database lock according to project timelines.
• Provide technical guidance and support to clinical data management team members and study sites.
• Ensure all data management activities comply with regulatory requirements (e.g., FDA, EMA, SAHPRA) and industry best practices (e.g., CDISC standards).
• Collaborate with statisticians, clinical operations, and other stakeholders to meet project data requirements.
• Contribute to the development and improvement of data management SOPs and processes.

Requirements

• Bachelor's degree in Computer Science, Statistics, Life Sciences, or a related field.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotech industry.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm).
• Strong understanding of clinical trial processes, database design, and data validation techniques.
• Knowledge of CDISC SDTM and ADaM standards is highly desirable.
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple projects and work effectively in a team environment.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth and certifications in data management.
• Exposure to a diverse range of clinical studies and therapeutic areas.
• Supportive and collaborative team culture.
• Pension fund and medical aid contributions.