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Clinical Project Manager
hace 2 meses
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: Maintain a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and Country/Cluster/Hub personnel.
- Training and Site Readiness: Conduct or coordinate training for CRAs to support site readiness to recruit and study execution, ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee, and SOP requirements.
- Local Investigator Meetings: 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 the appropriate study budget responsible in Country and ensure timely TCF preparation and submission.
- Timely Delivery of Clinical Trial Documentation/Data: Submit and deliver high-quality clinical trial documentation/data in a timely manner.
- Performance against Study Commitments: Perform against study commitments at the country/cluster/hub level, including delivery of studies per defined timelines, number of patients, and quality.
- Delivery of Study Milestones: Deliver study milestones in adherence to prevailing legislation, GCP, Ethical Committee, and SOP requirements.
- Minimum 5 Years' Experience: 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 Knowledge: 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.