About the Role
Our client, a prominent pharmaceutical research company, is looking for a skilled Pharmaceutical Data Manager to join their dedicated team in Sandton, Gauteng, ZA . This crucial role involves overseeing the collection, management, and integrity of clinical trial data. You will be responsible for designing databases, developing data management plans, ensuring data quality, and preparing data for statistical analysis. The ideal candidate has a strong understanding of clinical data management processes, databases, and relevant regulatory requirements within the pharmaceutical industry. This is an exciting opportunity to contribute to the development of new therapies by ensuring the accuracy and reliability of critical research data.
Key Responsibilities
- Design, develop, and manage clinical trial databases using electronic data capture (EDC) systems.
- Develop and implement data management plans (DMPs) and data validation procedures.
- Oversee data entry, data cleaning, and query resolution processes to ensure data accuracy and completeness.
- Collaborate with clinical operations, biostatistics, and programming teams to define data requirements.
- Ensure compliance with data privacy regulations (e.g., GDPR, POPIA) and industry standards (e.g., CDISC).
- Perform quality control checks on data and databases to identify and rectify discrepancies.
- Prepare databases for database lock and support statistical analysis.
- Contribute to the development and maintenance of data management SOPs and working practices.
- Train study team members on data management procedures and EDC system usage.
Requirements
- Bachelor's degree in a relevant field such as Computer Science, Statistics, Bioinformatics, or a related scientific discipline.
- A minimum of 4 years of experience in clinical data management within the pharmaceutical or CRO industry.
- Proficiency with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva EDC).
- Strong understanding of clinical trial processes, database design, and data validation techniques.
- Knowledge of CDISC standards (SDTM, ADaM) is highly desirable.
- Familiarity with GCP and regulatory requirements for clinical data.
- Excellent analytical, problem-solving, and organizational skills.
- Strong written and verbal communication skills, with the ability to document processes clearly.
- Ability to work independently and as part of a cross-functional team.
Benefits
- Our client offers a competitive salary package, performance-based bonuses, and a comprehensive benefits program, including medical aid, retirement fund contributions, and ample paid time off.
- We provide opportunities for professional growth and development through ongoing training and access to industry conferences.
- This role is based at our offices in Sandton, Gauteng, ZA , in a modern and collaborative work environment.