Clinical Project Manager
hace 7 días
We are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team at Empresa reconocida. As a key member of our team, you will be responsible for overseeing the execution of clinical trials, ensuring timely delivery, and maintaining high-quality standards.
Key Responsibilities- Study Execution Planning: Collaborate with the Study Start-up Manager to develop country/cluster/hub study execution plans and timeline commitments.
- Recruitment and Site Participation: Participate in the recruitment sub-team and support the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time.
- Study Feasibility: Support the study feasibility by providing input to the study protocol and operational aspects of the study, as requested by the SSO Feasibility Manager.
- Protocol Knowledge and Training: Maintain a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and Country/Cluster/Hub personnel. Conduct or coordinate training, as needed, for CRAs to support site readiness to recruit and study execution.
- Local Investigator Meetings and Documentation: Conduct or coordinate local investigator meetings as needed and ensure relevant documentation of training is archived in the Trial Master File.
- Study Budget and Contract Negotiations: Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study conduct.
- Study Budget Tracking: Track study budget with appropriate study budget responsible in Country. Ensure timely TCF preparation and submission.
- Timely Delivery of Clinical Trial Documentation/Data: Timely submission and delivery of high-quality clinical trial documentation/data.
- Performance against Study Commitments: Performance against study commitments at the country/cluster/hub level, including delivery of studies per defined timelines (including study close out), number of patients, and quality.
- Delivery of Study Milestones: Delivery of study milestones in adherence to prevailing legislation, GCP, Ethical Committee, and SOP requirements.
- Minimum 5 Years' Experience in Clinical Research: Minimum 5 years' experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials.
- Strong Project Management Capabilities: Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues.
- International Standards and Regulations: Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations, and Novartis standards.
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Clinical Project Manager
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Clinical Project Manager
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Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completoAbout the Role**Job Summary**We are seeking an experienced Clinical Project Manager to join our team at Syneos Health, Inc. as a Sponsor Dedicated Clinical Project Manager. This is a home-based position in Spain, and we are looking for a professional with a strong background in clinical project management on global studies.Key Responsibilities**Project...
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Clinical Project Manager
hace 4 días
Barcelona, Barcelona, España Empresa reconocida A tiempo completoAbout the RoleWe are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team at Empresa reconocida. As a key member of our team, you will be responsible for overseeing the execution of clinical trials, ensuring timely delivery, and maintaining high-quality standards.Key ResponsibilitiesStudy Execution Planning:...
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Clinical Project Manager
hace 7 días
Barcelona, Barcelona, España Empresa reconocida A tiempo completoAbout the RoleWe are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team at Empresa reconocida. As a key member of our team, you will be responsible for overseeing the execution of clinical trials, ensuring timely delivery, and maintaining high-quality standards.Key ResponsibilitiesStudy Execution Planning:...
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