Senior Clinical Trial Manager
Abata TherapeuticsFull Time
Senior (5 to 8 years)
Maryland, United States
Candidates must possess a Bachelor's degree, with a Master's degree being preferred. A minimum of five years of experience in quality assurance for clinical trials, specifically with expertise in ICH/GCP compliance, is required. Certification in quality management, such as ASQ or equivalent, is also mandatory. Additionally, candidates must be U.S. citizens, able to pass a comprehensive background check including drug screening and a physical, and obtain a NACI for a Common Access Card.
The Quality Assurance Officer will be responsible for the daily Quality Assurance and Regulatory Compliance of all onsite Clinical Trial activities. This includes conducting internal audits, reviewing and analyzing data and documentation, and facilitating quality assurance monitoring by study sponsors. The role involves developing, maintaining, and assessing long-term quality assurance programs, collecting and utilizing data to inform these programs, and developing and implementing corrective actions while assessing their efficacy. The officer will also develop, maintain, and ensure compliance with Standard Operating Procedures (SOPs), adhering to Human Subjects' Protection, FDA, and current Good Clinical Practice (GCP) regulations, and ensuring all contractor study personnel remain trained. Responsibilities include coordinating with the Clinical Trials Center (CTC) team to ensure compliance, preparing monthly status reports, and potentially leading and directing the work of others.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.