Director, Clinical Data Management
Aveo Oncology - Cambridge, MA

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AVEO Oncology, Inc. is looking for an experienced clinical data management professional to occupy a leadership role, reporting directly to the VP, Clinical Operations. The candidate will assure operational excellence and leadership within Data Management in a growing organization.

Responsibilities:
  • Recruits, trains, mentors and manages AVEO internal data managers and consultants
  • Contributes to technical infrastructure of Data Management and process improvement
  • Provides operational leadership in planning and execution of the collection and handling of clinical data
  • Oversees DM related timelines and deliverables with the assigned AVEO Data Manager
  • Builds effective DM vendor relationships and participates in RFP development and selection of vendors
  • Supports budget and resourcing plans for all AVEO sponsored trials
  • Develops standards and process documentation, including Standard Operating Procedures and Work Instructions
  • Participates in cross-functional clinical development strategy committees as the DM representative
  • Assures compliance with industry quality standards, guidelines and procedures

Qualifications:
  • Masters, BA/BS degree or equivalent in a scientific or health care field preferred
  • Minimum of 10 years experience in clinical data management in the pharmaceutical/ biotechnology/ CRO setting with at least 4 years of experience in Oncology
  • Management experience, at least 5 years
  • Knowledge of medical terminology required
  • Knowledge of coding dictionaries (MedDRA, WHO Drug)
  • Excellent verbal and written communication skills as well as interpersonal and organizational skills
  • Proficiency in MS Office applications
  • Proficiency with data management systems
  • Knowledge of database design and database concepts
  • Preferable but not required: SAS, SQL, and Access
  • Experience with SDTM/CDASH

Aveo Oncology - 2 years ago - save job