Facebook pixel

Senior Clinical Data Manager
Posted on 3/25/2022
INACTIVE
Locations
Remote in USA • Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Data Science
Leadership
Management
PowerPoint/Keynote/Slides
Word/Pages/Docs
Requirements
  • Bachelor's degree in data science, other relevant discipline, or equivalent required. Advanced degree preferred
  • Minimum of 5 years of experience in managing EDC for medical device or in-vitro diagnostic device trials
  • Familiar with the FDA regulations relevant to clinical trials and EDC
  • Proficiency in MS Word, Excel and PowerPoint
  • Good organization and planning skills
  • Strong interpersonal skills and communication skills (both written and oral)
  • Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment
  • Ability to collaborate with the study team, cross functional team members and external collaborators
Responsibilities
  • Responsible for the implementation of EDC for various studies in NIPT and oncology
  • Responsible for developing and maintaining Data Management Plan throughout the studies
  • Develop clinical trial data specifications, including eCRF design, user requirements, query logic and data validation
  • Ensure clinical data within EDC is in high quality to lock/unlock and freeze/unfreeze as appropriate for statistical review
  • Coordinate the archiving of study databases and related documents
  • Perform site training for EDC and perform site close-out audit
  • Ensure data system compliance by following the established guidelines (e.g. FDA)
  • Participate in the preparation and presentation of data
  • This role works with PHI on a regular basis both in paper and electronic form and has an access to various technologies to access PHI (paper and electronic) in order to perform the job
  • Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
  • Must maintain a current status on Natera training requirements
  • Employee must pass post offer criminal background check
Natera

1,001-5,000 employees

Clinical genetic testing
Company Overview
Natera's mission is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation.
Benefits
  • Flexible medical plans
  • Investment options
  • Time off
  • Workplace perks
Company Values
  • A person behind every sample
  • Embrace diversity
  • Be accountable
  • Think team
  • Learn and nimble
  • Show me the data
  • Be ready to change the world
  • Integrity is in our DNA