About the Opportunity
We are partnered with a biotechnology company that is seeking a remote Associate Director of Clinical Data Management to support their Data Management (DM) department and all clinical development programs. This person is responsible for Electronic Data Capture (EDC) vendor oversight, project timeline management, clinical database setup through closeout, creation of data management documents, data metrics reporting, and data cleaning activities.
The annual base salary range is $150,000 to $225,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Act as the data management lead for one or more clinical studies including responsibility for all data management and back-end activities from database start-up through database lock
- Establish and oversee partnerships with DM vendors and other external partners
- Ensure clinical databases and external data files are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and regulatory submission
- Oversee data management vendors with respect to key performance indicators, metrics, program level deliverables, and timelines
- Review and provide feedback to the clinical team on study documents, including clinical monitoring plans, statistical analysis plans, and vendor specifications
- Ensure that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis, including raw datasets and annotated CRFs
Job Requirements
- Bachelor’s Degree required
- Minimum 10 years of clinical data management experience in biotechnology or pharmaceutical industry required
- Advanced knowledge of data management processes and systems
- Advanced knowledge of setting up Clinical Databases in Medidata Rave
