Clinical Team Manager - RIDV

Work Schedule

Environmental Conditions

Job Description

Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation

The Clinical Trial 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.What You'll Do:\u2022 Manage 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.\u2022 Develop 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.\u2022 Collaborate 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.\u2022 Ensure 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.\u2022 May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.\u2022 May 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.\u2022 May 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.Education & Experience Requirements:\u2022 Bachelor's degree or equivalent and relevant formal academic / vocational qualification\u2022 Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

\u2022 In 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.

\u2022 Looking for CTMs with experience in end-to-end study management of studies.

\u2022 Therapeutic experience preferred: prior respiratory area experience is strongly desired

Knowledge, Skills, Abilities:\u2022 Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams\u2022 Good planning and organizational skills to enable effective prioritization of workload\u2022 Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization\u2022 Capable of working effectively in a changing environment with complex/ambiguous situations\u2022 Familiarity with the practices, processes, and requirements of clinical monitoring\u2022 Good judgment and decision making skills\u2022 Effective oral and written communication skills, including English language proficiency\u2022 Capable of evaluating workload against project budget and adjusting resources accordingly\u2022 Sound financial acument and knowledge of budgeting, forecasting and fiscal management\u2022 Strong attention to detail\u2022 Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.\u2022 Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.Working Conditions and Environment:\u2022 Work is performed in an office environment with exposure to electrical office equipment.\u2022 Frequently drives to site locations and frequently travels both domestic and international.Why Join Us?When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You\u2019ll work in an environment where collaboration and development are part of the everyday experience\u2014and where your contributions truly make a difference.Apply today to help us deliver tomorrow\u2019s breakthroughs.