The Quality Assurance Specialist works in a Good Clinical Practices compliant setting as part of a global team, assessing quality compliance and ensuring that appropriate processes are followed.
Responsibilities- Work as directed within a Quality Assurance team to support project needs specified by a relevant project lead. Maintain the integrity of all data.
- Lead development of specific project elements with minimum supervision.
- Depending on project requirements, collect necessary data for projects, perform analytical activities, draft sections of reports or presentations for assigned projects.
- Provide regular progress reports and ensures deadlines are met.
- Routinely participate in project/client meetings.
- Ensure company core operating procedures are understood and implemented.
- Keep abreast of emerging trends, tools, and technologies.
- Other duties as assigned.
Education: Bachelor’s degree in life or computer sciences or other related discipline. Experience in a quality environment may be considered in lieu of aforementioned bachelor’s degree disciplines.
Experience: 3 to 5 years in a clinical research quality environment or other relevant experience.
Skills:
Analytical thinking and troubleshooting skills.
Complex problem-solving skills.
Ability to multitask and efficiently manage time.
Possess a strong working knowledge of:
Good Clinical Practice
ICH guidelines
software validation requirements
21 CFR Part 11, Annex 11 and other applicable regulations
Excellent verbal and written communication skills.
Must be detail oriented.
Proficient in the Microsoft office suite.
Knowledge of Trackwise Digital is a plus.
Top Skills
What We Do
Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com
