The individual will be responsible for planning, tracking, and oversight of clinical data acquisition and management activities, including managing vendors and coordinating resources to ensure efficient workflow. The responsibilities include building and enforcing the appropriate standards in the department that will enable collection, integration, and aggregation of clinical data from investigational sites, external vendors, and other relevant data sources in accordance with industry standards and regulatory requirements.
Develop/execute/review Data Management Plan or Data Management Oversite plan and Completion Guidelines. Write/review edit checks, establish query and QC/QA plans for clinical trials.
Lead selection vendors for EDC, and any other sources for data on new projects and participate in selection of IxRS
Assist statisticians, pharmacokineticists, clinical operations, physicians, and other scientists in resolving data management-related issues.
Guide and direct clinical data associates on study processes, serve as a back up on all study related projects.
Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards
Ensure data management -related SOPs are up-to-date and are FDA-compliant.
Manage the Clinical data management study budgets.
Performs other functions as required or assigned, e.g., QC of CSRs, submission-related documents etc
Bachelors Degree (BA/BS) Majoring in Math, Statistics, Computer Science or Biological Sciences or any Physical Sciences - Required
Master Degree (MS/MA) Majoring in Math, Statistics, Computer Science or Biological Sciences or Physical Sciences - Preferred
Bachelor's degree with 8 or more years of work experience in clinical data management in the Pharmaceutical arena. 10 or more years of relevant experience may be considered in lieu of a bachelors degree.
Master's degree with 6 or more years of work experience in clinical data management in the Pharmaceutical arena
Vendor management and selection experience
Proficient in clinical data collection and data management tools
Must be highly motivated, detail-orientated, and independent. - Advanced
Must be willing to adapt to small-company hands-on culture. - Advanced
Must have writing and communication skills. - Intermediate
Must have people management skills and able to maximize collaborations with CROs. - Advanced
Must be able to advise, train, and develop Clinical Data Associate - Intermediate
Experience with multiple EDC systems
Primary Location: US-NJ-Piscataway
Work Locations: Piscataway 1045 1045 Centennial Avenue Piscataway 08854
Job: Research & Analytics
Organization: Scientific Affairs
Job Type: Full-time
Job Posting: Sep 25, 2018, 7:16:52 AM