Senior Manager/Associate Director, Clinical Data Management

OverviewSenior Manager/Associate Director, Clinical Data Management (Hybrid; Greater Boston, MA)ResponsibilitiesAct as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studiesInteract and manage relationships with other functional areas to ensure high quality data management activitiesOversight of data collection tools (EDC, DTAs, EDC integrations) and essential documents (DMP, UAT Documents, data edit specifications, annotated case books and data entry guidelines)Participate in User Acceptance Testing Activities for the applicable Data Collection ToolsPerform Quality Control for the data completeness and accuracy.Participate in and support data cleaning, query generation and resolution and review of medical coding as needed.Responsible for adhering to the Data Management timelines and budget.Provide technical expertise to help in the use of technologies for Data Management and the clinical study team.Contribute to the development of lessons learned and best practices as well as help develop SOPs and internal working procedures and process improvement initiatives.Contribute to the establishment of systems and tools to help ensure clinical data security and integrity.Qualifications8+ years' experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience5+ years managing vendor relationships/partnerships in a global environment.Must have advanced knowledge of Data Management processes and systemsSolid understanding of CDISC standards requiredData Visualization Tool experience preferred.Experience using standardized medical terminology, including but not limited to MedDRA and WHODrug.Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment.J-18808-Ljbffr