MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

Leads/supervises a team of 2 or more professionals.

First level manager of a work team that could comprise professionals, technical and/or administrative staff.

Typically without budget or hire/fire authority.

Focuses on mentoring, coaching, and coordination.

MAIN RESPONSIBILITIES

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Primary responsibility is ensuring implementation of quality plan at every stage of the Clinical Trial process/operations.

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Implement quality assurance regulations.

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Write and revise standard operating procedures.

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Support and facilitate audits and regulatory inspections.

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Support Quality Assurance Manager in supervision of all quality control aspects of the process (laboratories studies, clinical research, testing, operations).

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Ensure that standards are met and report potential issues either with quality or reliability of testing procedures.

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Lead implementation of new regulations.

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May support quality training.

QUALIFICATIONS

Education

Education Level

Major/Field of Study

Or

Education Level

Associates Degree (± 13 years)

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Experience/Background

Experience

Experience Details

Minimum 4 years