H3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pJoin us as a Senior Clinical Team Manager within the Hematology/Oncology team - Make an Impact at the Forefront of Innovation /p pThe Senior Clinical Team Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced 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. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. /p pWe are seeking experienced Clinical Team Managers (CTMs) to join our growing Hematology/Oncology team. Ideal candidates will bring regional and/or global CTM experience, along with expertise in one or more of the following therapeutic areas and indications: /p ul liOvarian Cancer /li liSickle Cell Disease /li liNon-Hodgkin Lymphoma /li liAcute Myeloid Leukemia (AML) /li liGlioma /li liHead Neck Cancer /li liPancreatic Cancer /li liProstate Cancer /li liNon-Small Cell Lung Cancer (NSCLC) /li liBreast Cancer /li liColorectal Cancer /li liExperience with Radiopharmaceuticals, Cell Gene Therapy, and CAR-T therapies is highly desirable. /li /ul h3What You’ll Do: /h3 ul liManage 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 complex projects. /li liDevelop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure 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 required. Collaborate with the project manager to prepare,



organize, and present at client meetings, including bid defense and hand-off meetings. /li liCollaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead 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. /li liEnsure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. /li liMay communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. /li liMay coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees. /li liMay provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements. /li /ul h3Education Experience Requirements:



/h3 ul liBachelor's degree or equivalent and relevant formal academic / vocational qualification /li liPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). /li /ul pIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. /p h3Knowledge, Skills, Abilities: /h3 ul liGood leadership skills, effective at mentoring and training, and capable of motivating and integrating teams /li liGood planning and organizational skills to enable effective prioritization of workload /li liSolid interpersonal and problem solving skills to enable working in a multicultural matrix organization /li liCapable of working effectively in a changing environment with complex/ambiguous situations /li liFamiliarity with the practices, processes, and requirements of clinical monitoring /li liGood judgment and decision making skills /li liEffective oral and written communication skills, including English language proficiency /li liCapable of evaluating workload against project budget and adjusting resources accordingly /li liSound financial acumen and knowledge of budgeting, forecasting and fiscal management /li liStrong attention to detail /li liSolid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. /li liGood computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. /li /ul h3Working Conditions and Environment: /h3 ul liWork is performed in an office environment with exposure to electrical office equipment. /li liFrequently drives to site locations and frequently travels both domestic and international. /li /ul h3Why Join Us? /h3 pWhen you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. /p h3We are unable to consider junior CTMs at this time. /h3 pThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p #J-18808-Ljbffr

📌 Senior ctm, hematology/oncology (Italia)
🏢 Thermofisher Scientific
📍 Italia