Remote Pharmaceutical Data Manager - Global Trials

Placements24; Klerksdorp; Hybrid; ZAR 550,000 - 900,000; Full time

Job summary

Placements24 is seeking a remote Pharmaceutical Data Manager to oversee the design, validation, and integrity of clinical databases across international trials. The role emphasizes GCP/21 CFR Part 11 compliance, SDTM/ADaM familiarity, and collaboration with global teams from home.

You will implement DMPs, supervise data cleaning, and ensure timely data delivery for regulatory submissions while managing multiple studies in a remote, globally distributed environment.

Qualifications

• 5+ years of clinical data management experience in pharma/biotech.
• Experience with EDC systems and data validation techniques.
• Knowledge of regulatory requirements (GCP, 21 CFR Part 11).
• Familiarity with CDISC standards is desirable.

Responsibilities

• Design, build, and manage clinical databases using EDC systems.
• Develop and implement data management plans (DMPs) for clinical trials.
• Create and maintain data validation specifications, edit checks, and data review guidelines.
• Perform data cleaning, including query generation, resolution, and reconciliation with external data sources.
• Oversee the UAT of clinical databases and tools.
• Ensure compliance with regulatory requirements (GCP, 21 CFR Part 11) and SOPs.
• Collaborate with clinical operations, biostatistics, programming, and medical writing teams.
• Generate data management reports and supervise data archiving timelines.

Skills

Analytical thinking

Problem solving

Attention to detail

Communication skills

Time management

Remote work discipline

Education

Bachelor's degree in Computer Science, Statistics, Bioinformatics, Pharmacy or related field

Master's degree in related field (preferred)

Tools

Medidata Rave

Oracle InForm

Veeva EDC

Job description

About the Role

Our client, a globally recognized pharmaceutical company at the forefront of therapeutic innovation, is seeking a highly skilled and meticulous Remote Pharmaceutical Data Manager . This position is integral to the success of our client's international clinical research programs, ensuring the integrity, accuracy, and completeness of clinical trial data. Working remotely, you will be responsible for the design, development, and implementation of clinical databases, data validation processes, and data reconciliation activities across multiple studies. This role requires a deep understanding of data management principles, regulatory requirements (e.g., FDA, EMA, SAHPRA), and therapeutic areas, particularly in a remote setting. You will collaborate with a diverse team of scientists, statisticians, and clinical operations personnel to deliver high-quality data essential for regulatory submissions and decision-making. The opportunity is based from home, covering studies relevant to the Klerksdorp, North West region and beyond, offering significant professional growth.

Key Responsibilities

Design, build, and manage clinical databases using EDC systems, ensuring adherence to study protocols and regulatory standards. Develop and implement data management plans (DMPs) for clinical trials, outlining data collection, validation, and quality control procedures. Create and maintain data validation specifications, edit checks, and data review guidelines. Perform data cleaning activities, including query generation, resolution, and reconciliation with external data sources. Oversee the UAT (User Acceptance Testing) of clinical databases and associated tools. Ensure compliance with all applicable regulatory requirements (e.g., GCP, 21 CFR Part 11) and company SOPs. Collaborate with clinical operations, biostatistics, programming, and medical writing teams to ensure seamless data flow and integrated reporting. Contribute to the development and maintenance of data management standards and best practices. Generate data management reports, including status updates, query metrics, and database lock timelines. Manage data archiving and retrieval processes upon study completion.

Requirements

Bachelor's or Master's degree in Computer Science, Statistics, Bioinformatics, Pharmacy, or a related field. Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry. Proficiency with electronic data capture (EDC) systems (e.g., Medidata Rave, Oracle InForm, Veeva EDC). Strong understanding of clinical trial processes, database design, data validation techniques, and regulatory requirements (GCP, 21 CFR Part 11). Experience in developing and executing data management plans (DMPs). Excellent analytical, problem-solving, and critical thinking skills. Strong written and verbal communication skills, with the ability to effectively communicate technical information to non-technical audiences. Ability to work independently, manage multiple projects, and meet strict deadlines in a remote environment. Familiarity with CDISC standards (SDTM, ADaM) is highly desirable. Must be able to work effectively from home, demonstrating self-discipline and time management skills relevant to the Klerksdorp, North West region and national coverage.

Benefits

Our client offers a competitive salary, a comprehensive benefits package including health, retirement, and life insurance, and significant opportunities for professional development and career advancement. Working remotely provides unparalleled flexibility and work-life balance, eliminating commute times and allowing for greater personal autonomy. You will gain exposure to cutting-edge clinical research projects and collaborate with international teams. Our client is committed to fostering a culture of innovation, collaboration, and continuous learning. This role offers the chance to contribute meaningfully to the development of new medicines from the comfort of your home, serving the wider pharmaceutical landscape relevant to areas like Klerksdorp, North West .