Remote Pharmaceutical Data Manager

Placements24; Vereeniging; Hybrid; ZAR 800,000 - 1,100,000; Full time

Benefits offered by this job

Competitive salary

Home office stipend

Advanced technology resources

Excellent health insurance

Retirement savings plan

Job summary

Placements24 is seeking a meticulous Remote Pharmaceutical Data Manager to oversee clinical data management for globally distributed trials. The role focuses on maintaining data integrity, developing DMPs, and ensuring GCP/ICH compliance from a fully remote setting.

You will work with international clinical operations, biostatistics, and programming teams, handling large datasets and advanced validation tools while supporting database lock activities and data transfer to statistical analysis.

Qualifications

• Bachelor's degree in a scientific, healthcare, or related field.
• Minimum of 5 years of experience in clinical data management.
• Proficiency in using EDC systems (e.g., Medidata Rave, Oracle Clinical).
• Thorough understanding of GCP and ICH guidelines.
• Experience in developing data management plans (DMPs) and edit checks.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Effective written and verbal communication for remote teams.
• Ability to work independently and manage multiple projects.
• Experience with database programming or statistical software is a plus.

Responsibilities

• Develop, implement, and maintain clinical data management plans (DMPs).
• Oversee data collection, cleaning, validation, and reconciliation.
• Design and manage clinical databases and EDC systems.
• Collaborate with investigators and internal teams to resolve data queries.
• Ensure compliance with GCP, ICH, and regulatory requirements.
• Generate data management reports and metrics.
• Participate in CRF development and study documents.
• Assist in selecting and implementing data management technologies.
• Provide training to site personnel on data management procedures.
• Support database lock activities and data transition to analysis.

Skills

Analytical thinking

Problem solving

Organizational skills

Communication skills

Self-motivation

Remote collaboration

Education

Bachelor's degree

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role Our client, a cutting-edge pharmaceutical research organization, is seeking a meticulous and experienced Remote Pharmaceutical Data Manager to join their globally distributed team. This fully remote position is central to managing and ensuring the integrity of clinical trial data, supporting the development of vital new medicines. The ideal candidate will be adept at handling large datasets, implementing robust data management plans, and ensuring compliance with regulatory standards such as Good Clinical Practice (GCP). This is a unique opportunity to contribute to groundbreaking pharmaceutical research from the comfort of your own home, leveraging your expertise in data management within a fast-paced, innovative environment. You will collaborate with international clinical operations, biostatistics, and programming teams, playing a crucial role in the success of clinical trials. This role is entirely remote, offering flexibility and autonomy.

Key Responsibilities

• Develop, implement, and maintain comprehensive clinical data management plans (DMPs) for assigned studies.
• Oversee data collection, cleaning, validation, and reconciliation processes to ensure data accuracy and completeness.
• Design and manage clinical databases, electronic data capture (EDC) systems, and data validation tools.
• Collaborate with clinical investigators, site staff, and internal teams to resolve data queries in a timely manner.
• Ensure all data management activities are conducted in compliance with GCP, ICH guidelines, and relevant regulatory requirements.
• Generate data management reports, including status updates, query statistics, and database lock metrics.
• Participate in the development and review of Case Report Forms (CRFs) and other study-related documents.
• Contribute to the selection and implementation of new data management technologies and processes.
• Provide training and support to clinical site personnel on data entry and data management procedures.
• Participate in database lock activities and support the transition of data to statistical analysis.

Requirements

• Bachelor's degree in a scientific, healthcare, or related field.
• Minimum of 5 years of experience in clinical data management, with a strong focus on pharmaceutical or biotech clinical trials.
• Proficiency in using EDC systems (e.g., Medidata Rave, Oracle Clinical) and data validation tools.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements related to clinical data.
• Experience in developing DMPs, edit checks, and data review procedures.
• Excellent organizational skills, with a strong attention to detail and ability to manage multiple projects simultaneously.
• Strong analytical and problem-solving skills.
• Effective written and verbal communication skills, comfortable working in a remote team environment.
• Ability to work independently, manage time effectively, and meet deadlines.
• Experience with database programming or statistical software is a plus.

Benefits

• Competitive salary
• Generous home office stipend
• Advanced technology resources
• Excellent health insurance
• Retirement savings plan

We foster a flexible and empowering work culture that prioritizes employee well-being and work-life balance. This fully remote position allows you to contribute to critical pharmaceutical advancements from anywhere, making it a truly flexible and rewarding career opportunity.