clinical operations in cambridge

posted
job type
contract
salary
US$ 100 per hour
apply now

job details

posted
location
cambridge, massachusetts
job category
Biotechnology & Pharmaceutical
job type
contract
salary
US$ 100 per hour
reference number
25799
apply now

job description

Job Title: Clinical Data Management & Technology (CDMT) Contractor V

Position Description

  • 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)

Position 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 Company 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

Position Requirements

  • 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

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.