Covance IRT Speciailist in Philadelphia, Pennsylvania

Job Overview

IRT Specialist

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.

  • Manages UAT planning and creates UAT documentation – UAT Test Plan, test scripts, and defect tracker.

  • Coordinates documentation and closure of issues.

  • 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 converting complex technical and business requirements into clear test plan and test cases.

  • 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 converting complex technical and business requirements into clear test plan and test cases.

  • 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 Number 2018-26091

Job Category Clinical Data Management

Position Type Full-Time

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