Clinical Project Manager

hace 7 días


Barcelona, Barcelona, España Empresa reconocida A tiempo completo
About the Role

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
  1. Study Execution Planning: Collaborate with the Study Start-up Manager to develop country/cluster/hub study execution plans and timeline commitments.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Study Budget Tracking: Track study budget with appropriate study budget responsible in Country. Ensure timely TCF preparation and submission.
Requirements
  1. Timely Delivery of Clinical Trial Documentation/Data: Timely submission and delivery of high-quality clinical trial documentation/data.
  2. 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.
  3. Delivery of Study Milestones: Delivery of study milestones in adherence to prevailing legislation, GCP, Ethical Committee, and SOP requirements.
Desirable Requirements
  1. 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.
  2. Strong Project Management Capabilities: Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues.
  3. 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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