Senior Clinical Data Manager

  • Location:Cambridge, MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Manager/Supervisor

SUMMARY

The Senior Clinical Data Manager is responsible for providing technical oversight of the clinical data management activities of CRO vendors contracted to perform data management services.  This role will perform review of relevant CDM documents, validation of data systems, and general data review and management.  The Senior Clinical Data Manager is responsible for delivering high quality clinical data and documentation.

 

RESPONSIBILITIES:

  • Review and approval of CDM documentation, including electronic Case Report Forms (eCRFs), Data Management Plans, Data Validation Specifications, Data Transfer Agreements, Data Review Guidelines, Data Analysis Plans and eCRF Completion Guidelines
  • Ensure that delegated and outsourced tasks are performed according to quality standards
  • Lead the data management process from study start-up through database lock for Phase I and Phase II studies
  • Able to work successfully with minimal supervision and without a fully developed process infrastructure
  • Ability to collaborate in a cross-functional matrix-style organization
  • Participate in User Acceptance Testing for clinical study databases
  • Review clinical study documentation including protocol, project timelines, meeting minutes, and study notes to file
  • Ensure that CDM documentation is filed according to SOPs ; review CDM files for completeness and accuracy
  • Perform data cleaning activities including processing queries, performing ongoing data review, identifying issues, data trends and tracking them through resolution
  • Perform oversight for the data transfer process

EDUCATION AND EXPERIENCE: 

  • Bachelor’s or Masters’ level degree with at least 5 years of pharmaceutical, biotech or CRO experience; small biotech/pharmaceutical company experience is a plus
  • Oncology experience is a plus
  • Experience with using data management methodologies and technologies
  • Working knowledge of FDA, GCP, ICH, SDTM standards and CDISC data handling standards and specifications as well as clinical trial methodology
  • Experience performing oversight of vendors
  • Medidata RAVE experience required
  • Demonstrated skills with Microsoft Office (Excel, PowerPoint) required
  • Experience working with safety data and coding dictionaries (MedDRA and WHODD)
  • Experience with J-Review, Spotfire or similar data review/visualization systems are a plus
  • Ability to program in SAS a plus

 

REQUIREMENTS:

  • Project level experience as a Clinical Data Manager
  • Thorough knowledge of the data management process and experience in specialized data management skills (e.g., SAE reconciliation, central laboratory, data reconciliation.)
  • Proficiency with clinical data collection and review process; proven success in achieving data milestones from CRF design to database lock
  • Demonstrated advanced knowledge of data management systems, practices, and standards
  • General knowledge of cross-functional clinical development is necessary
  • Flexible personality, creative problem solver with proven ability to work independently and collaboratively in a fast-paced, results-oriented and dynamic environment
  • Strong interpersonal and leadership skills, positive outlook and ability to work well within a matrix team structure
  • Able to work remotely until COVID restrictions are lifted, at which time you will be required to report to the office in Cambridge, Mass for at least 3 days a week.