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Clinical Data Management & Technology (CDMT) Contractor
Ref No.: 18-04355
Location: Cambridge, Massachusetts
Start Date: 04/18/2018
Job Title: Clinical Data Management & Technology (CDMT) Contractor

Location: Cambridge, Massachusetts

Position Summary: Manages all aspects of the clinical trial data management process from study start up to database lock for trials conducted through an outsourced partner / Contract Resource Organization (CRO)


Duties and Responsibilities:
  • Acts as the data expert and represents CDMT on study team as applicable
  • Works with CRO to ensure data collection tools capture protocol requirements
  • Identifies and resolves data flow process issues in collaboration with the project team
  • Defines data handling conventions, quality acceptance and auditing criteria for data collection and data deliverables
  • Provides guidance and sponsor approval per CRO SOPs and process exceptions
  • Serves as an internal CDMT expert for cross functional team members
  • Liaises with third-party vendors in support of study team escalations
  • Monitors timelines to ensure data management-related deadlines or contributions to study deliverables are proactively defined and met


Supplemental Activities:

None defined

Qualifications:
Experience: BS/RN/MS/RPH degree in health-related field preferred with 5+ years of clinical data management experience in the pharmaceutical/biotechnology industry; knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; strong comprehensive understanding of CDISC (SDTM), clinical experience in the oncology, neuroscience, or gastrointestinal preferred; EDC and coding experience with WHO Drug and MedDRA desirable
Other:
  • Strong knowledge of SOPs, GCP standards and CDM systems
  • Detail orientation
  • Excellent written and verbal communication skills
  • Ability to focus on multiple projects of different duration and complexity
  • Ability to work independently with minimal guidance