Job Details

  • Title: Associate Director, Clinical Data Management
  • Code: RCI-09289
  • Location: Foster City California (CA) 94404
  • Posted Date: 12/28/2020
  • Duration: 6 Months
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  Job Description

This is s 100% Remote / Work From Home role

We are seeking a highly motivated individual to join us as an Associate Director, Clinical Data Management (CDM). You will work with the Biostatistics, Programming, and Clinical Operations teams in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Director, CDM. The Associate Director, CDM will be responsible for overseeing all aspects of clinical data management for clinical development programs with guidance from the Director, CDM. This position will be responsible for managing CDM vendors, project timelines, working with Statistical Programming to create data quality reports, clinical data collection, and data review. The Associate Director, CDM will also work with Clinical Operations, Safety and Regulatory as necessary.

  • Project level coordination and day to day oversight of Data Management tasks
  • Provide CDM expertise for database set up, CRF design, and data cleaning to efficiently ensure high quality data
  • Manage vendors, and ensure appropriate resources are available to meet the demands of the assigned clinical trials
  • Manage CDM deliverables in coordination with internal and external cross functional teams.
  • Collaborate with Statistical Programming to create internal data quality checks in support of Data Management activities
  • Review clinical data on an ongoing basis to ensure quality data
  • Provide guidance to study teams and external vendors regarding the technical aspects of clinical database structure and programming
  • Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
Requirements:
  • Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
  • State of the art understanding of data standards (CDISC, CDASH) in the clinical trial environment
  • Experience managing vendors
  • Experience with Medidata RAVE including database build, edit check programming, and data extraction
  • Experience with SAS programming (recommended)
  • Experience with Spotfire programming (recommended)
  • Experience managing clinical data management deliverables for regulatory filings
  • Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
  • 10+ years experience in Oncology
  • 10+ years CDM experience within clinical development