Manager Clinical Data Management

2 weeks ago


Cambridge, United States ClinLab Staffing Full time

MANAGER DATA MANAGEMENT

Cambridge, MA, US


RESPONSIBILITIES

  • Manage and supervise a team of Clinical Data Managers (CDMs)
  • Oversee each project assigned to the team
  • QC each deliverable prior to sending to internal or external clients
  • Prepare and present individual performance reviews
  • Provide mentorship to DM staff and suggest/implement solutions for complex issues
  • Assist staff with interactions with sponsors and managing vendors
  • Keep supervisor updated on study progress and staff management through routine meetings
  • Maintain a positive, progressive, and proactive management style and communication
  • Develop and update data management SOPs and training manuals
  • Conduct data management training as well as study specific training for the CDM and study teams
  • Provide input from the data management perspective regarding the design of clinical trial protocols
  • Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
  • Oversee and participate in the process of data review and query generation procedures
  • Oversee and participate in the coding of medical terms
  • Oversee/define/perform SAE reconciliation processes
  • Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system
  • Ensure proper completion of UAT of EDC system and modules
  • Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
  • Review queries and trends to ensure data completeness and integrity
  • Review/prepare training materials and user guides for EDC data collection tools, deliver user training
  • Participate in client and team meetings as required advising on best practices as appropriate
  • Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies
  • Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes
  • Implement technical solutions, new tools, and process improvement strategies
  • Lead large and complex projects
  • Identification of project scope changes
  • Present at sales and marketing meetings for prospective clients
  • Provide strategic input to the department and company goals
  • Lead key departmental goals and initiative

EDUCATION

  • Minimum BS in a scientific or health related field or equivalent

EXPERIENCE

  • Minimum of 8-10 years of experience in Clinical Data Management
  • Minimum 2 years supervisory experience is required

SKILLS

  • Knowledge of GCPs and regulatory agency guidelines
  • Familiarity with medical terminology is required
  • Skilled in the use of data management software application, Medidata RAVE
  • Excellent organizational and time management skills
  • Strong collaboration and leadership skills
  • Excellent oral and written communication skills
  • Strong interpersonal skills



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