Data Management, Quality and Compliance Manager

Alkermes   •  

Waltham, MA

5 - 7 years

Posted 241 days ago

This job is no longer available.

Main Duties and Responsibilities    

  • Development and oversight of Data Management and Clinical Programming/Technical Solutionsprocesses,quality standardsand training      
    • Oversees quality and consistency with organizational strategies and processes across therapeutic areas or across stages of development (i.e., early versus late stage processes)        
    • Develops and maintains SOPs, processes, templates, training for Alkermes’ internal  Data Management and Clinical Programming/Technical Solutions ; represents function as point-of-contact for cross-functional processes
    • Develops and provides fit-for-purpose training on data management/Clinical Programming/Technical Solutions processes, changes to the operating model, or in support of new processes or implementation of industry best practices
    • Reviews and summarizes  Data Management milestone/quality delivery performance metrics for the DM leadership team against defined department or functional KPIs/KQIs
    • Facilitates quality or process input of Data Management  preferred vendors or strategic partners
    • Leads process improvement or Data Management or Clinical Programming/Technical Solutions training initiatives
    • Keeps current with external best practices, data standards evolution and regulatory requirements, and proactively communicates and consults with Data Management and Clinical Programming/Technical Solutions on potential impacts to studies/programs   
  • Provides input to or facilitates Data Management and Clinical Programming/Technical Solutions related activitiesassociated with Clinical Quality Assurance efforts,risk management, Regulatoryinspections or data vendoraudits
    • Serves as Data Management and Clinical Programming/Technical Solutions representative on Clinical Quality Board
    • Acts as functional point-of-contact for evaluating functional quality issues or CAPAs
    • Provides input to quality risk management plans as a functional SME or drives functional quality risk–based approaches
    • Coordinates and/or supports functional team preparation for mock inspections or regulatory inspections in collaboration with Clinical Compliance

  Operational Responsibilities      

  • Accountable for the development of a Quality Management Framework supporting overall quality in the execution of Data Management and Clinical Programming/Technical Solutions activities and deliverables        
  • Responsible for  eTMF functional strategy and quarterly review and remediation with DM leads for eTMF Functional quality/completeness
  • Maintains  Data Management startup and end of study master timeline templates; summarizes study milestones or operational metrics and provides periodic summary to DM Leadership team
  • Consultant for Data Management Leads on the overall consistency, quality and completeness of the Data Management Plan (DMP) or other key Data Management Study documentation
  • Performs or support UAT activities and documentation, as needed        
  • Responsible for developing a Lessons Learned Framework and analyzing trends, supporting identifying process improvements
  • May provide support to Lead Data Managers on study specific tasks, as needed


Minimum Education & Experience Requirements:


  • Minimum of a BS in life sciences or computer science degree
  • Demonstrated Data Management experience in the Biotech/Pharma/CRO industry (at least 5 years)    
  • Functional Quality, and/or Process  Expertise (at least 3 years)    
  • Demonstrated current understanding of GCP and regulatory requirements as related to data management systems, vendor oversight activities    
  • Demonstrated  understanding of data management  flow, database structures, data standards and data management  best practices for  CRF design, database development, data handling and reporting    
  • Experience in developing, managing, and assuring traceability of data across clinical data sources and  clinical data management systems including electronic data capture (EDC)  and  other external data systems
  • Excellent interpersonal, organizational, and multi-tasking skills
  • Strong leadership skills and ability support cross-functional teams
  • Ability to negotiate and influence others across functional areas
  • Excellent written and verbal communication skills