Project Svcs Lab Qc Analyst

hace 2 semanas

Buenos Aires, Argentina Q² Solutions A tiempo completo
Internal Job Description

Job Overview

In accordance with the process of designing and launching global clinical research studies, perform an independent QC review and ensure study set-up process and procedures are adhered to during the start-up and amendment phase; review of source documentation and database configuration versus sponsor protocol; provision of guidance in the design and organization of project components; develop and maintain best practices within the organization.


Essential Functions

  • QC of project database(s) and requisition forms versus the sponsor protocol and sponsor specific requirements.
  • Cross functional collaboration to ensure QC reviews reflect current process and quality standards.
  • Work with Setup Managers and/or Project Managers and/or Setup Coordinators to resolve problems or quality findings established during the QC review.
  • Oversee and maintain adherence to QC timelines to ensure client needs are met.
  • Analyze and identify quality trends and opportunities for training and process improvements.
  • Collaborate with QC counterparts to ensure global consistency in the study setup process.
  • Participate in external and internal audits as required.
  • Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications

  • Bachelor's Degree Science related field Req
  • Minimum 2 years of clinical or research industry experience, including 1 year Setup related and/or Project Management experience. Equivalent combination of education, training and experience.
  • Possess strong interpersonal skills for interaction with senior internal stakeholders and on occasion senior members of sponsor organizations and demonstrated ability to meet deadlines.
  • High attention to detail as demonstrated through a track record of achievement in the role of Setup Manager, Senior Setup Specialist, Project Manager or equivalent.
  • Demonstrated computer proficiency with Microsoft Office, Q Squared Solutions systems and ELVIS.
  • Possess an understanding of medical and clinical research terminology.
  • Demonstrated ability to work in a fast paced, deadline driven environment.
  • Knowledge of Setup Management and/or Project Management processes and terminology would be beneficial.
  • Excellent organizational skills and operational skills. Excellent written and verbal communication skills including good command of the English language.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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