Quality Assurance Position Available In Suffolk, Massachusetts
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Job Description
Job Title:
Quality Assurance Job Description We are seeking a dedicated Quality Assurance professional with a BA/BS degree and a strong background in Clinical Trial Management. This role requires a minimum of 3 years of experience for Clinical Trial Managers (CTM) and 5 years for Senior CTM positions. The ideal candidate must be willing to travel both domestically and internationally, and possess a comprehensive understanding of FDA, EMA, GCP, and ICH regulations and guidelines. This position demands a detail-oriented individual who can provide effective leadership to clinical sites and Contract Research Organizations (CROs). Responsibilities Manage clinical trials independently with a focus on Phase I gene therapy. Provide oversight and direction to CROs to ensure compliance and quality standards. Demonstrate knowledge of
FDA/EMA/GCP/ICH
regulations and guidelines. Travel domestically and internationally to oversee trial sites. Take initiative in problem-solving and ensure trial protocols are adhered to. Collaborate effectively in a team setting while also working independently. Essential Skills Minimum 3 years of Clinical Trial Management for CTM and 5 years for Senior CTM. Experience in Phase I clinical trials, particularly in gene therapy. Strong understanding of
FDA/EMA/GCP/ICH
regulations and guidelines. Ability to manage and interact with CROs. Proven global experience in clinical trials. Additional Skills & Qualifications BA/BS Degree. Strong multi-tasking, time management, and organizational skills. Detail-oriented with excellent problem-solving capabilities. Work Environment The work environment involves managing clinical trials, which may require travel to various sites internationally and domestically. You will be working with advanced gene therapy technologies in a collaborative team setting. The role demands flexibility and adaptability in a dynamic clinical trial environment, ensuring compliance with industry regulations while overseeing the trials.
