Clinical Data Manager

The Clinical Data Manager is responsible for all aspects of data management activities in support of assigned clinical studies while working without appreciable supervision. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications. Ensures that Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and established processes are followed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Ensures that quality of services meets internal and external customer requirements.

What You’ll Do:

• • Performs or coordinate all data management activities for assigned studies, as appropriate:
  • Protocol and Statistical Analysis Plan (SAP) review and input
  • Case Report Form (CRF) development and maintenance
  • Edit Check specifications development and maintenance
  • Data Management Plan development and maintenance
  • Data Quality checks and discrepancy management
  • Analyzes data, identifies trends; prepares data tables for reports
  • Study Database setup testing and Edit Check programming testing
  • External data handling
  • Device reconciliation and tracking for investigational product
  • Participate in Post Market Surveillance reporting as appropriate
  • Additional study specific activities
  • Ensures that all data management activities for assigned studies are completed on time and with high quality
  • Communicates effectively with peers, study teams and management as appropriate to support studies and goals
  • Leads efforts to improve Data Management processes, as needed/assigned
  • Represents the Data Management group at study team meetings and cross-functional task forces
  • Trains and mentors other Clinical Data Associates (CDAs) and Clinical Data Coordinators (CDCs)
  • Applies and promotes best practices and established standards
  • Serves as a liaison between the study team and clinical data operations
  • Is a Subject Matter Expert (SME) in most areas within Data Management
  • Understands the whole clinical trial process and regulations that apply, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies
  • Communicates and collaborates with all levels of employees, customers, contractors, and vendors
  • Suggest and drafts departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines
  • Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procedures and processes
  • Performs other related duties and responsibilities, as assigned

Who You Are:

• • Bachelor’s degree in computer sciences or a scientific discipline
  • At least 5 years of experience in a medical device clinical data management position is strongly preferred
  • Comprehensive knowledge of data management practices from protocol design to database development and study closure
  • Proficiency with using EDC databases, preferably OpenClinica; intermediate knowledge of SOL; general understanding of SAS
  • Experience working under Good Clinical Practices, Good Clinical Data Management Practices, and other FDA regulations and guidelines is required
  • Demonstrated solid oral and written communication skills and analytical/ problem-solving skills are essential as is the ability to clearly communicate basic data management concepts to those outside data management
  • Able to effectively manage multiple projects and timelines