Clinical Data Manager

3 weeks ago

Centurion, South Africa DFNet Research Full time

**Clinical Data Manager**

**South Africa | Remote**
- DFnet provides data management, biostatistics, and software development services for industry, non-profit, and academic organizations worldwide. Since 2004, DFnet’s people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global health. DFnet helps researchers manage and analyze data across 18 therapeutic areas with clinical sites in over 35 countries. Our work includes HIV, TB, Malaria, Ebola, and other tropical diseases. Our motto is “helping people help people on a global scale.” In our supporting role, we are fortunate to work with some of the world’s top research scientists who have dedicated their lives to challenging global health issues_
- The individual will be able to work remotely._

**This Position**

Applies knowledge of health care to clinical data management responsibilities from study development through study closure, including CRF creation, study database setup, testing, and documentation; internal and external study team training; data collection, tracking, and cleaning; study closeout activities. Participate in company software and infrastructure development. Provides training and mentoring to Clinical Data Coordinators.

**You will**
- Act as a liaison between clients, clinical management, subcommittees and project teams as needed.
- Communication with study sponsor and collaborators.
- Translate protocol requirements into data collection instruments.
- Collaborate within study team.
- Train and mentor Clinical Data Coordinators.
- Develop and provide written and oral presentations as needed.
- Develop Case Report Forms (eCRFs/CRFs).
- Define and tests databases.
- Develop edit checks.
- Develop study specific Data Management Plans, maintain study documents.
- Perform and document study closeout activities.
- Manage data quality control activities.
- Validate data, review data queries, and generate QC reports.
- Perform additional study and projects, as needed.

**Must-haves**
- Bachelor's degree in Public health or related field.
- Experience with clinical trial research and/or database management.
- Knowledge of clinical trial activities and Good Clinical Data Management Practices

**Nice-to-haves**
- Master’s degree or equivalent experience.
- At least two years of experience with DFnet’s proprietary software and/or clinical trial data and/or research studies.
- Experience with Electronic Data Capture (EDC).
- Experience with international clinical trials.
- Knowledge of FrameMaker.
- Familiarity with CDISC standards.

**We are looking for**
- Demonstrated ability to multi-task and appropriately prioritize work assignments.
- Ability to work independently and potentially, remotely.
- Ability to work collaboratively in a physical or virtual team environment.
- Flexibility to work in changing research environment.
- Exceptional attention to detail.
- Proficient computer skills.
- Management skills.
- Ability to establish and maintain productive in office or remote work relationships.
- Strong verbal and written communication skills.
- Ability to comply with industry regulatory requirements and standards and DFnet Research Standard Operating Procedures (SOPs).
- This job description is not a comprehensive listing of the duties or of this job. These may change at any time with or without notice._

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