Remote
Covance

Title: IRT Project Manager

Job Category: Clinical Data Management
Job Desc: Job Overview
IRT Project Manager
Permanent, salaried

Remote from anywhere in the U.S. or Canada

Responsibilities

  • Responsible for IRT system initial implementation, maintenance, and closure.
  • Ensure comprehensive understanding of requirements and design to provide quality deliverables.
  • Organizes kick-off meeting and team meetings.
  • Coordinates review and sign-off of requirements and release documents.
  • Directs teams during development and testing for initial implementation and updates.
  • Reviews and Approves UAT documentation
  • Manages post-production change controls.
  • Facilitates database lock activities with study team, vendor, and other stakeholders. Coordinates decommissioning and archiving.
  • Advise the team and stakeholders, informing on the processes that will be completed to enable system implementation and updates.

Experience Required

  • Minimum 3-5+ years of experience in clinical systems such as CTMS, ePRO, IXRS, EDC or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Strong oral and written communication skills. Experienced project leader and presenter.
  • Able to work both independently and collaboratively across multiple functional areas.
  • Proficiency in understanding complex business requirements and communicating those to technical and project teams.
  • Understanding of Drug Development and Clinical Trial Processes
  • Understanding of Data Management Processes
  • In-depth knowledge of Good Clinical Practices
  • Understanding of Clinical Research System Development Lifecycle
  • Must have sound problem resolution, judgement and decision-making skills.
  • Ability to prioritize tasks effectively and manage multiple projects simultaneously.

Education/Qualifications

  • Degree in a mathematical, computing, life sciences, or related discipline

Experience

  • Minimum 3-5+ years of experience in clinical systems such as CTMS, ePRO, IXRS, EDC or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Strong oral and written communication skills. Experienced project leader and presenter.
  • Able to work both independently and collaboratively across multiple functional areas.
  • Proficiency in understanding complex business requirements and communicating those to technical and project teams.
  • Understanding of Drug Development and Clinical Trial Processes
  • Understanding of Data Management Processes
  • In-depth knowledge of Good Clinical Practices
  • Understanding of Clinical Research System Development Lifecycle
  • Must have sound problem resolution, judgement and decision-making skills.
  • Ability to prioritize tasks effectively and manage multiple projects simultaneously.

Job Type: Full Time
C: 17.6