[Remote] Sr. Clinical Team Manager/Lead- Internal Medicine

Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global leader in scientific innovation, and they are seeking a Senior Clinical Team Manager to oversee clinical trials in various therapeutic areas including Internal Medicine. The role involves managing clinical operations, ensuring compliance with regulations, and delivering high-quality results within specified timelines.ResponsibilitiesManage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities, e.g. process improvements, manage complex programs, have wider management or project coordination responsibilitiesDevelop 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 meetingsCollaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate 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 departmentEnsure 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 clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financialsCommunicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issuesMay coordinate all start-up activities and ensure that essential document quality meets the expectation of Regulatory Compliance Review. Ensure timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibility may vary based on project timelinesProvide input into preparation of forecast estimates for clinical activitiesResponsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirementsSkillsBachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). CTM and/or GCTM experience will be neededIn 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 roleStrong leadership skills, effective at mentoring and training, and capable of motivating and integrating teamsStrong planning and organizational skills to enable effective prioritization of workload and workload of team membersStrong interpersonal and problem-solving skills to enable working in a multicultural matrix organizationSolid understanding of change management principlesComprehensive understanding of the practices, processes, and requirements of clinical monitoringStrong judgment, decision making, escalation, and risk management skillsEffective oral and written communication skills, including English language proficiencyCapable of evaluating own and team members workload against project budget and adjust resources accordinglyStrong financial acumen and knowledge of budgeting, forecasting and fiscal managementStrong attention to detailIn-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etcStrong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etcCapable of independently managing clinical only studiesPreferred therapeutic experience: Dermatology, GI, (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology, (RA, SLE, Gout), Cell & Gene Therapy and CAR-T in AutoimmuneThe team also prefers candidate that live in the West or Central regionBenefitsThis position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountCompany OverviewThe world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs. It was founded in undefined, and is headquartered in Écublens, Vaud, CH, with a workforce of 10001+ employees. Its website is https://www.thermofisher.com/de/de/home/industrial/spectroscopy-elemental-isotope-analysis/oes-xrd-xrf-analysis/optical-emission-spectrometry-oes.html.