Description
ABOUT QYNAPSE
Qynapse is on a mission to advance the accuracy and reliability of screening and monitoring across central nervous system (CNS) diseases in both clinical routine settings and in clinical trial applications.
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 Qy Score® produces a wide range of automated neuroimaging biomarkers to assist physicians making clinical care decisions and monitoring patients over time. These Qy Score® biomarker solutions are also applied to improve measures of efficacy and safety monitoring across CNS clinical trials. Qy Predict®, 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%):
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, f MRI 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: Ability to analyze logs, data, and resolve technical issues.

QUALIFICATIONS

• At least 5 years' experience in the pharmaceutical or biotechnological industry in managing clinical trials and/or a similar technical role - Medical imaging experience is preferred.
• Master’s degree in Life Sciences, Computer Science, or a related field (advanced degree preferred).
• Language: Fluent in English; French is a plus.

CONTRACT, RENUMERATION AND PERKS

• Full time
• Competitive Salary
• Individual performance bonus
• Stock-options
• Health benefits

LOCATION
Paris (France), London (UK) - Hybrid mode possible.
TSP Talent Solutions and our customers are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)