A biopharmaceutical company in the research-stage of developing innovative medicines for auto-immune and viral diseases. They are looking to fill a Clinical Data Manager role. Upon speaking with the manager, they are actively reviewing resumes with biotech/pharma experience This is a minimum 6 month contract role with possible extensions and remote opportunities.
The focus of a CDM is to ensure study launch, conduct, and closeout and performed following SOPs, and ICH GCP guidelines.
- Collaborate and communicate with vendors and project teams to provide updates about progress reports and project statuses
- Handle clinical trial data management through activities such as protocol review, CRF design (case report form), database development, and validation programming
- Prepare information for internal meetings and study timelines
- Manage the clinical study budget, data management plan (DMP), case report form (CRF), SAS annotated CRFs, data handling plan, data review plan, data quality plan, and data transfer specifications
- In charge of CRO data management function audits and inspections
- Provide support to the development and implementation of company policies and process improvement initiatives
- Design and produce standard and customized status, as well as tracking reports
- Handle site query audits, document data issues, and ensure an accurate locked database for analysis
- Facilitate interactions with data management vendors to streamline projects and processes
- Bachelor's degree in clinical, biological, or mathematical sciences, nursing or equivalent related field education is required
- Master's degree preferred
- Experience with drug development and clinical monitoring procedures is required
- Minimum of 8 years of clinical research project management
- 2 years of managing CROs
- Extensive knowledge with FDA regulations, ICH GCP, GCDMP
- Well-rounded in Word, Excel, PowerPoint
If you're interested, don't hesitate. Apply now!