Clinical Team Manager
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Job Description
Clinical Trial Manager overseeing global clinical studies, regulatory submissions, monitoring, and trial deliverables for Thermo Fisher Scientific. Managing teams, timelines, quality, resources, and project financials.
Responsibilities:
- Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
- Assume Clinical Study Manager responsibilities on small or less complex projects when required
- Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to data quality and master action plans
- Set up, organize, maintain, and archive relevant Trial Master File sections and study materials
- Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
- Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings
- Lead clinical team meetings and coordinate with clinical and cross-functional teams to maintain timelines, resources, quality, and interactions
- Implement and train standardized clinical monitoring processes
- Monitor clinical activity timelines and metrics, provide status updates, review projects and monitoring visit reports, implement recovery actions, and manage CRF collection and query resolution
- Conduct or co-monitor clinical trials and assess performance against contractual obligations
- Conduct Accompanied Field Visits and manage project financials in smaller regions when required
- Communicate with study sites regarding protocols, patient participation, case report forms, and study issues
- Coordinate study start-up activities and ethics committee and regulatory submissions when required
- Review and follow up on ethics committee questions and ensure essential document quality
- Provide input into clinical activity forecasts and manage clinical resources, responsibilities, delegation, and additional resource requirements
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities
- Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities
- FSO/CRO experience
- Global CTM experience managing global teams
- Indication experience in ovarian, sickle cell, non-Hodgkins lymphoma, multiple myeloma, glioma, head and neck, pancreas, prostate, non-small cell lung, breast, colorectal, radiopharmaceutical, cell and gene therapy, and/or CAR-T
- Leadership, mentoring, and training skills
- Planning and organizational skills
- Interpersonal and problem-solving skills
- Ability to work in multicultural matrix organizations and changing environments with complex or ambiguous situations
- Familiarity with clinical monitoring practices, processes, and requirements
- Judgment and decision-making skills
- Effective oral and written communication skills, including English language proficiency
- Ability to evaluate workload against project budget and adjust resources
- Financial acumen and knowledge of budgeting, forecasting, and fiscal management
- Strong attention to detail
- Understanding of ICH/GCP and FDA guidelines
- Good computer skills, including Outlook, Excel, and Word
- Frequent domestic and international travel and driving to site locations
Benefits:
- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused workplace
- Domestic and international travel opportunities
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