About the Role
Our client, a cutting-edge pharmaceutical research company, is seeking an experienced Remote Pharmaceutical Data Manager to oversee the collection, management, and integrity of clinical trial data. This fully remote position is ideal for a detail-oriented professional with a strong understanding of data management systems and pharmaceutical research processes. You will be responsible for designing, developing, and implementing data management plans, ensuring that all data collected is accurate, complete, and compliant with regulatory standards. You will work closely with clinical operations, biostatistics, and programming teams to ensure seamless data flow and timely database lock. This is an exceptional opportunity to contribute to life-saving research from the comfort of your own home, impacting global health initiatives. We are looking for a proactive individual with excellent communication skills and a proven ability to manage complex datasets in a remote setting.
Key Responsibilities
- Lead the design, development, and implementation of clinical data management plans (DMPs).
- Oversee the setup and maintenance of Electronic Data Capture (EDC) systems.
- Develop data validation checks and edit checks to ensure data accuracy and completeness.
- Manage data cleaning activities, including identifying and resolving data discrepancies.
- Collaborate with biostatisticians and programmers to ensure timely database lock.
- Generate data management reports and metrics for project status updates.
- Ensure compliance with Good Clinical Practice (GCP), relevant regulations (e.g., FDA, EMA), and company SOPs.
- Participate in clinical trial team meetings and provide data management expertise.
- Contribute to the development and maintenance of data management standards and best practices.
- Train and mentor junior data management personnel as needed.
Requirements
- Bachelor's degree in a relevant scientific field, Computer Science, or related discipline.
- Minimum of 4 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
- Extensive experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Inform).
- Strong understanding of clinical trial processes, data standards (e.g., CDISC), and regulatory requirements.
- Proficiency in database design, data validation, and data cleaning processes.
- Excellent analytical and problem-solving skills with meticulous attention to detail.
- Outstanding written and verbal communication skills, with the ability to effectively communicate in a remote environment.
- Proven ability to manage multiple projects and meet deadlines.
- Self‑motivated and able to work independently with minimal supervision.
- Experience with CDISC SDTM and ADaM is highly desirable.
Benefits
- Our client offers a competitive salary and benefits package, including comprehensive health insurance, retirement fund contributions, and generous paid time off. This is a fully remote position, allowing you the flexibility to work from anywhere. You will have the opportunity to work on diverse and impactful clinical research projects, contributing to global health advancements, with our main operations based near Nelspruit. We foster a culture of collaboration and continuous learning. This role is key to ensuring the quality and reliability of data generated from our clinical trials.