Senior Clinical Data Manager/Clinical Data Manager
Infinity Pharmaceuticals, Inc. - Cambridge, MA

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Infinity Pharmaceuticals, Inc. is an innovative cancer drug discovery company focused on discovering and developing therapeutics that target cancer cell survival utilizing Infinity’s novel small molecule chemistry platform.

Position Overview

Manages all aspects of the clinical trial data management process from study start up to database lock for Electronic Data Capture (EDC) trials and for trials managed in house and those contracted to Clinical Research Organizations (CROs)

REQUIREMENTS/QUALIFICATIONS

Bachelor’s or equivalent degree in health-related field preferred with 3+ years of experience in clinical data management in the pharmaceutical/biotechnology industry or equivalent; electronic data capture experience and working knowledge of Oncology and/or Inflammation indications, SDTM and C-DASH principles desirable

RESPONSIBILITIES

  • Primary Data Management (DM) contact and contributor for assigned clinical project(s) / program(s)
  • Serves as a member of Clinical Study Teams
  • Monitors timelines and ensures that clinical data management deadlines are met with quality
  • Liaises with third-party vendors such as CROs, EDC vendors and central laboratories in a project-manager capacity in support of timelines and data-related deliverables
  • Responsible for working with database builders to develop EDC databases and revisions
  • Help develop specifications and UAT requirements for database and test according to UAT Plan
  • Specify requirements for electronic and manual edit checks
  • Create and revise data management documentation
  • Review and query clinical trial data per the Integrated Data Review Plan and Data Validation Specifications
  • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
  • Train clinical personnel on CRF and EDC, as needed
  • Coordinate with Pharmcovigilance on adverse event reconciliation
  • Review and provide feedback on protocols, Statistical Analysis Plans and CSRs
  • Provide leadership for cross-functional and organization-wide initiatives, where applicable
  • Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
  • Ensures adherence to data management standards
  • May train and/or supervise the daily responsibilities of more junior staff as assigned
TECHNICAL KNOWLEDGE

  • Proficiency in the area of clinical data collection, cleaning and analysis
  • Demonstrates superior project management skills
  • Understanding of ICH and regulations as they pertain to data management
  • Working knowledge of at least one EDC system
  • Understands and routinely considers the big picture
  • Experience with SDTM/C-DASH is a plus
Required Skills

Required Experience

Infinity Pharmaceuticals, Inc. - 17 months ago - save job - block
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About this company
Infinity is an innovative drug discovery and development company dedicated to discovering, developing, and delivering best-in-class...