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TFS is a Global CRO headquartered in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent. The Clinical Research Manager (CRM) will function operationally as a member of a Project Team being responsible of coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations. The CRM will be reporting to the Project Manager being responsible of certain aspects of project activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.
• Responsible for overseeing all aspects of monitoring and site Management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements. • Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables. • Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports. • Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out. • Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison. • Implement monitoring/recruitment plans and support also the design of CRF completion guidelines. • Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up. • Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level. • When delegated by Project Manager, track and approve investigators payments. • Assist Project Manager in CRA training program, training CRAs on study procedures and requirements and ensuring a proper handover when there is a replacement of CRA. • Provide input to project manager about activities time registration and consumption ensuring appropriate revenue recognition and revenue forecasting. • Participate in Investigators Meetings and present monitoring requirements and deliverables when requested. • Interact with CRAs Line Managers (in case they are not) to ensure the proper CRA study allocation and discuss performance issues if any to ensure a proper follow up and resolution plan.
• Degree in clinical, science or health related field • 5+ years of clinical research experience, as CRA in Oncology studies, including relevant on-site monitoring experience. • 2+ years of LCRA experience • Able to work in a fast paced environment with changing priorities • Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas • Possess the understanding of Good Clinical Practice regulations, ICH guidelines • Ability to work independently as well as in a team matrix organization and multiple projects • Excellent written and verbal communication skills as well as computer skills • Excellent organizational and Line Management skills • Ability and willingness to travel up to 20-30%
Additional Responsibilities: • Actively contribute to the organization and development of initiatives and processes to enhance the work at TFS. • May participate in proposal and budget development for new business opportunities • May participate in bid defense meeting preparations in partnership with Business Development and Senior Operations staff
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