Clinical Trial Manager
Il y a 2 mois
Location: Paris, IDF, France
Date Updated: Oct 10, 2024
Job ID: 6159
**Description**
**ABOUT QYNAPSE**
Headquartered in France, in the United States and in Canada, the Qynapse neuroscience team, is dedicated to building tools and software that analyze brain images and related markers to identify and track neurodegeneration and neuroinflammation across CNS disorders. With the support and guidance of CNS disease experts around the world, we strive to create clearer, more accurate and reliable predictors and objective quantitative measures across CNS disorders, such as Alzheimer’s disease, multiple sclerosis, and Parkinson’s disease.
Powered by proprietary Artificial Intelligence, our solution QyScore® produces a wide range of automated neuroimaging biomarkers to assist physicians making clinical care decisions and monitoring patients over time. These QyScore® biomarker solutions are also applied to improve measures of efficacy and safety monitoring across CNS clinical trials. QyPredict®, our predictive technology, is being designed to transform what we know about CNS disease trajectory to impact clinical trial design and outcomes.
**CURRENT POSITION**
Qynapse is seeking a highly motivated and experienced Clinical Trial Manager to support our expanding pharmaceutical and CRO clients trial needs. This position will combine technical and clinical project management skills to oversee clinical trials using our automated brain image analysis software suite. The Clinical Trial Manager will play a pivotal role in the planning, execution, and management of clinical trials related to neuroimaging endpoints across CNS disorders. This position requires a strong background in clinical trial management, regulatory compliance, and an understanding of CNS therapeutic areas. It involves distinct phases of trial scope definition, contract negotiation, and operational execution for CNS disease clinical trials.
**Key Responsibilities**
**Clinical Trial’s Scope Definition and Contract Management (30%)**:
- ** Client Consultation for Biomarkers selection and Clinical Trial’s Scope definition**: Work directly with clients and Qynapse’ VP of Medical Imaging to understand specific needs for biomarkers, determining relevance and feasibility for each trial.
- ** Quoting and Pre-start Services**: Collaborate with VP of Medical Imaging, CTO and R&D teams for accurate project quoting; contribute to pre-start services by defining project scope and resources needed.
- ** Tender Response and Client Interactions**: Respond to tenders with tailored solutions, engage in detailed discussions with clients to refine project needs and expectations.
- ** Contract Review**: Review and understand contract liabilities and legal clauses**.**:
- ** Co-ordinate Risk Analysis and Go/No Go Decisions**: Analyze potential risks associated with new projects, lead decision-making meetings to determine project viability.
**Technical Operations and Clinical Trial Execution (70%)**:
- ** Trial Monitoring and Problem Solving**: Oversee daily trial operations, troubleshoot software and data-related issues or data transfer problems.
- ** Technical Support and Issue Escalation**: Provide Level 2 technical support for operational issues; escalate complex technical challenges to the R&D team, involving them in problem-solving as necessary.
- ** Client Technical Liaison**: Act as the primary technical contact for clients during the trial, ensuring clear communication and resolution of technical inquiries.
- ** Data and Image Compliance Monitoring**: Regularly check that data and images received from clients meet quality standards; address any compliance issues promptly.
- ** Quality Control and Continuous Oversight**: Perform ongoing quality control of incoming images, ensure the software suite operates effectively, and intervene when anomalies or errors are detected.
- ** Participation in Audits**: Engage in audit processes in accordance to regulatory processes, reviewing logs, data, algorithms, and software capabilities to ensure compliance and identify areas for improvement.
**PROFILE EXPECTATIONS**
- ** Project Management**: Ability to manage multiple clinical trials, meeting deadlines and effectively coordinating stakeholders. Proven ability to lead cross-functional teams and manage complex projects.
- ** Clinical Knowledge**: Experience in clinical trials, with a strong knowledge of regulatory requirements and guidelines (FDA, EMA, ICH) related to clinical trials, in particular GCP and data managements principles.
- ** Technical Proficiency**: Experience and strong knowledge of MRI image acquisition and processing. Skills in additional modalities including PET, fMRI and DWI also preferred. Familiarity with technical processes and tools, such as basic Linux shell scripting skills, and a willingness to learn complex tasks.
- ** Communication and Negotiation**: Strong cross-functional internal team collaboration skills.
- ** Problem-Solving**
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