Website Labcorp Drug Development
The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Clinical Data Management expertise within a varied and dynamic environment, then this is a fantastic opportunity.
- Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
- Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF according to these specifications.
- Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
- Coordinate the development and testing of data management systems edit / data validation checks diagnostics and special listings / procedures used as tools for the data review and discrepancy management activities.
- Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
- Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
- Develop Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
- Additional relevant work experience will be considered in lieu of formal qualifications.
- Excellent oral and written communication and presentation skills.
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
- Relevant work experience in data management with technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
- Financial management of gross revenues in excess of $250K per year.
- Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
- In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
- University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Company: Labcorp Drug Development
Vacancy Type: Freelance
Job Location: South Africa
Application Deadline: N/A