Alimentiv
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management
Clinical Compliance Specialist
April 18
Alimentiv
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management
📋 Description
• The Clinical Compliance Specialist will act as an advisor on ICH GCP and other regulations/standards governing clinical research activities and will support study teams by driving and overseeing quality and compliance for clinical studies. • This role will partner with study delivery teams focusing on first-time quality, issue management and maintaining an inspection-ready state. • The Clinical Compliance Specialist will provide expertise to support clinical study delivery, clinical compliance leadership and customers.
🎯 Requirements
• 7+ years of related experience • Bachelors Degree • Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development • Expertise with ICH-GCP principles, ISO 20916 and ISO 14155 • Strong interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback. • Superior analytical skills focusing on identifying potential compliance issues, investigating root causes, brainstorming and identifying alternatives and assessing the effectiveness of actions. • Strong skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues. • Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge. • Ability to plan, organize, prioritize and manage workload independently, keeping the patient and customer at the focus. • Superior critical thinking skills • Knowledge of Quality by Design principles
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