Detalles de la oferta

.At 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 through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.**Summarized Purpose**:Accountable for achieving the final clinical deliverable (usually clean data from valuable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from expert team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs.**Key responsibilities**:- Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less sophisticated projects.- Develops clinical tools (e.G. Supervising Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as the need arises. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.- Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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