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Clinical Research Quality Manager
PayCompetitive
LocationWashington/District Of Columbia
Employment typeFull-Time
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Job Description
- Req#: 45C0E77156
Employer Industry: Clinical Research
Why consider this job opportunity:
- Competitive salary with a comprehensive benefits package, including medical benefits, PTO, and holiday pay
- Opportunity for career advancement and growth within the organization
- Work remotely with a collaborative team
- Chance to lead and train clinical research staff while ensuring high-quality standards
- Involvement in impactful clinical trials that contribute to advancements in healthcare
What to Expect (Job Responsibilities):
- Oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines
- Conduct quality visits to clinical trial sites to assess compliance with study protocols, SOPs, and regulatory requirements
- Develop, review, and implement SOPs to standardize clinical research processes and ensure consistency and quality
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and data management
- Provide training and guidance to clinical research staff on quality standards, regulatory requirements, and SOPs
What is Required (Qualifications):
- Bachelor's degree in a relevant field (e.g., life sciences, healthcare, or related discipline); advanced degree preferred
- Minimum of 15 years of experience in clinical research, including overseeing clinical trials and creating SOPs
- In-depth knowledge of GCP guidelines, regulatory requirements, and clinical trial processes
- Strong analytical, problem-solving, and decision-making skills
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
How to Stand Out (Preferred Qualifications):
- Proven track record of supervising and leading teams
- Experience in data collection, analysis, and management for clinical trials or scientific research studies
- Detail-oriented with a strong commitment to quality and compliance
- Ability to manage multiple priorities and work under tight deadlines
- Eligibility to obtain and maintain a U.S. Federal Government Public Trust Clearance
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