Team Lead - EDC Development

at  Genesis Global Group

Montréal, QC, Canada -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate27 Dec, 2024Not Specified02 Oct, 20242 year(s) or aboveDesign,Documentation Practices,Clinical Practices,Technology,Computer ScienceNoNo
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Description:

Job Summary: In collaboration with the Senior Director of Data Management and Bioinformatics, develops and maintains software and database systems ensuring compliance with specifications security, quality controls and trains company personnel on the use of the software.

Essential Functions: The following duties represent the principal job duties however they are not all inclusive:

  • Performs troubleshooting, bug tracking and evaluates software performance and proposes solutions
  • Manages software versioning
  • Prepares user manual and instructions documents
  • Provides software technical support
  • Provides software reviews
  • Ensures that the developed software adheres to company SOPs
  • Works in compliance with project timelines
  • Performs training
  • Experience in documentation and validation of clinical trials software program
  • Participates in the development and review of SOPs
  • Acts as a substitute for the Database Administrator, if required
  • Manages requests for the development of software, if required
  • Reviews Software Data
  • Some knowledge for data cleaning and database design
  • Some knowledge as related to the submission of products for regulatory approval

KNOWLEDGE OF:

  • Programming technology and advancements
  • Requirements of Good Clinical Practices
  • Requirements of Good Documentation Practices
  • Requirements of 21 CFR Part 11 for Handling of Electronic Records

EXPERIENCE AND EDUCATION:

  • University degree in Computer Science
  • 2-4 years of relevant work experience
  • Experience with object-oriented analysis and design
  • Continuously using and applying technology to optimize processes

How To Apply:

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Responsibilities:

Essential Functions: The following duties represent the principal job duties however they are not all inclusive:

  • Performs troubleshooting, bug tracking and evaluates software performance and proposes solutions
  • Manages software versioning
  • Prepares user manual and instructions documents
  • Provides software technical support
  • Provides software reviews
  • Ensures that the developed software adheres to company SOPs
  • Works in compliance with project timelines
  • Performs training
  • Experience in documentation and validation of clinical trials software program
  • Participates in the development and review of SOPs
  • Acts as a substitute for the Database Administrator, if required
  • Manages requests for the development of software, if required
  • Reviews Software Data
  • Some knowledge for data cleaning and database design
  • Some knowledge as related to the submission of products for regulatory approva


REQUIREMENT SUMMARY

Min:2.0Max:4.0 year(s)

Information Technology/IT

Software Engineering

Graduate

Computer science

Proficient

1

Montréal, QC, Canada