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Responsibilities:
- Lead the development, revision, and maintenance of complex clinical study and amendments.
- Author and finalize global lab specification documents (GLSD) and other related documents, as needed.
- Participate in client interactions during study start-up activities and/or during study amendment process.
Qualifications:
- BA/BS, or equivalent experience in scientific field.
- 1 yrs clinical trials or other laboratory experience required.
- Proficient in Microsoft Office and desktop publishing or word processing.
Working Knowledge:
- Maintain a general working knowledge of Food & Drug Administration (FDA).
- Understand Medical & Healthcare Regulatory Agency (MHRA).
- Follow Good Clinical Practice (GCP), ICH and other pertinent regulations.
ACM Global Laboratories
ACM Global Laboratories contributes to patient well-being through high-quality work. They focus on being patient-driven and have teams globally.