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 Set-up Managers and/or Project Managers and/or Set-up 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 set-up 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 Set-up 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 Set-up Manager, Senior Set-up 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 Set-up 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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