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Senior Clinical Team Manager – HemOnc
Thermo Fisher Scientific. Lead clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in leading clinical trials, particularly in hematology and oncology, while ensuring compliance with ICH GCP and FDA guidelines. Proficient in clinical monitoring practices, project management, and effective communication across cross-functional teams.
Highest-signal resume keywords
Clinical Trial ManagementHematology And Oncology ExpertiseICH/GCP ComplianceLeadership And MentoringClinical Monitoring Practices
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchProject CoordinationData Quality ManagementRegulatory SubmissionsCRF DevelopmentMonitoring Plan DevelopmentBudget ManagementResource ForecastingRisk ManagementChange Management
Soft Skills
LeadershipMentoringProblem-SolvingInterpersonal SkillsDecision-Making
Tools & Technologies
OutlookExcelWord
Industry Keywords
Clinical TrialsTherapeutic AreasPatient ParticipationTrial Master FileStudy Start-Up Activities
About the role
Key responsibilities & impact- Lead clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP
- Manage clinical aspects of trials from launch through closeout
- Coordinate Clinical Management members allocated to projects on a regional or country basis
- Partner with Project Managers to establish training, tracking, and quality systems
- Own clinical deliverables within agreed timelines, budgets, and customer expectations
- Develop monitoring plans, monitoring guidelines, data quality plans, and related clinical tools
- Contribute to Master Action Plans and maintain relevant Trial Master File sections
- Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
- Prepare, organize, and present at client, bid defense, and hand-off meetings
- Lead clinical team meetings and collaborate cross-functionally to maintain timelines, resources, interactions, and quality
- Implement and train teams on standardized clinical monitoring processes
- Monitor clinical activity timelines, metrics, monitoring visit reports, CRF collection, query resolution, and recovery actions
- Communicate with study sites regarding protocols, patient participation, case report forms, and study issues
- Coordinate study start-up activities, regulatory submissions, and ethics committee follow-up when applicable
- Provide clinical resource forecasts, assign and delegate responsibilities, and identify additional resource needs
- Mentor and train junior staff
- May assume regional Lead CTM, Clinical Study Manager, program leadership, process improvement, or project coordination responsibilities
- May conduct Accompanied Field Visits and manage project financials
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 8+ years of previous relevant experience
- Minimum of 8 years in clinical research
- Experience leading global clinical teams on hematology and oncology clinical trials
- Experience in relevant therapeutic areas including 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 CART-T
- Advanced degree or equivalent experience in life sciences, medicine, or a related field preferred
- Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, and financial skills
- Comprehensive understanding of clinical monitoring practices, processes, and requirements
- Understanding of change management principles
- Knowledge of relevant regulations, including ICH/GCP and FDA guidelines
- Effective oral and written communication skills, including English language proficiency
- Strong computer skills using Outlook, Excel, Word, and similar applications
- Ability to independently lead clinical-only studies
- Ability to evaluate workload against project budgets and adjust resources
- Ability to travel independently up to 20%
- Ability to work in non-traditional work environments and use standard office equipment and technology
Benefits
Comp & perks- Health and wellbeing support
- Healthy and balanced work environment
- Professional development through mentoring and training
- Opportunities to participate in innovative global healthcare projects