Covance IXRS Validation Lead in Helena, Montana

Job Overview

IXRS/eCOA Validation Lead

Permanent, salaried

Remote from anywhere in the U.S. or Canada

Responsibilities

  • Proactively follow-up with customers and third-party vendors to ensure comprehensive understanding of requirements and design in order to provide quality deliverables.

  • Active participation in study team meetings.

  • Review and provide input on requirements and specifications.

  • Create validation documentation – UAT Test Plan, test scripts, and defect tracker.

  • Direct teams during testing execution for initial implementation and updates. Function as point of contact during UAT for team members, triaging and resolving issues as needed.

  • Manage UAT plans and timelines, ensuring that team members adhere to the schedules and timetables for the completion of projects.

  • Advise the team and stakeholders, informing on the processes that will be completed to enable system implementation.

Education/Qualification

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

Experience

  • Minimum 2-4+ 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.

  • 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, judgment 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 2-4+ 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.

  • 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 2018-22905

Job Category Other

Position Type Full-Time

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