Lavori attuali relativi a Senior Clinical Trials Manager - Milan - Quanta part of QCS Staffing
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Clinical Trial Manager
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Clinical Research Associate
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Clinical Research Associate II
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Clinical Research Associate
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Milan, Italia MAI Fortrea Development Limited A tempo pienoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Sr. Clinical Research Associate
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Milan, Italia Allucent A tempo pienoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will independently...
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Sr. Clinical Research Associate
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Milan, Italia Allucent A tempo pienoAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will...
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Project Manager
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Clinical Sales Representative
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Market Access Specialist
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Project Manager
3 mesi fa
Milan, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...
Senior Clinical Trials Manager
3 mesi fa
- Independently manage all components of a clinical trial, leading a cross-functional study team.
- The assigned clinical trial may be of high complexity or high risk.
- Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP / ICH requirements and Kyverna SOPs.
- Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)
- Partner efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct.
- Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites.
- Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations.
- Manage external vendors with oversight of activities.
- Oversee implementation and maintenance of Trial Master File for inspection readiness.
- Develop study documents and tools including study, informed consent forms, project plans, budgets, study logs, templates, and other materials as needed.
- Collaborate with clinical team and vendors to develop study-specific documents, and maintenance of internal files
- Provide study status updates and reports to senior management.
- Participate in ongoing study data reviews and data cleaning activities.
- Established Cell Therapy / CAR T study experience required.
- BS degree with minimum 7+ years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
- Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience highly preferred.
- Strong leadership, effective decision making, and problem-solving skills required.
- Established knowledge of clinical operations.
- Working knowledge of relevant GCPs and FDA / EMA regulations.
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
- Excellent written and verbal communication skills.
