Associate Director, Clinical Data Management Direct Hire MA

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Job ID: 16039 Direct Hire MA

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Associate Director, Clinical Data Management

Our client is a highly-regarded cell/gene therapy company in the greater Boston area and they are seeking an experienced, highly-motivated Associate Director level candidate to lead their Clinical Data team! You will collaborate with and help other teammates to adhere to study protocols, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. The main function of this role is to provide strategic planning and effectively manage external vendors and junior personnel.

  • Lead a team through daily activities as well as the oversight/management of extended projects
  • Participate in the development of database standards and ensure that when CROs perform data management activities that they adhere to these standards
  • Review clinical database-related output and deliverables produced by CROs on an ongoing basis to provide technical and business expertise
  • Ensure that all clinical data received and processed are completed and accurate for all parameters required by the study protocols in collaboration with cross-functional colleagues.
  • Understand and maintain documentation that SOPs are followed for CDM
  • Oversee CROs in their delivery of data management milestones

Requirements:

  • Bachelor of Science degree preferred, preferably in health related field and computer science
  • 8+ years’ experience in clinical data management in the pharmaceutical and biotechnology
  • Experience in all phases of data management for clinical trials is preferred
  • Knowledge of GCP, regulatory and ICH Guidelines as applicable to data management
  • For the best fit, you should be a results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues.  

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the US to be considered and must be commutable to the Cambridge area or able to relocate with limited assistance. 

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.