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Associate Clinical Manager, CTC Hub
Thermo Fisher Scientific. Oversee daily line management for assigned clinical operations staff .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Operations Management, including oversight of clinical trial processes, staff development, and regulatory compliance. Proficient in stakeholder communication and project management within clinical settings.
Highest-signal resume keywords
Clinical Operations ManagementLeadership ResponsibilityTrial Master File UnderstandingGood Clinical PracticeCTMS Proficiency
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 Trial OperationsProject ManagementTraining Program DevelopmentRisk-Based MonitoringQuality Assurance AuditsPerformance ManagementDocumentation PracticesSite Records CoordinationMetrics EvaluationProcess Improvement
Soft Skills
CoachingCommunicationStakeholder ManagementCollaborationProblem-Solving
Tools & Technologies
CTMSPreclarusClaritySite Collaboration ToolTrial Data Tracking Systems
Industry Keywords
Good Clinical PracticeClinical Operations LandscapeTMF Reference ModelSite CollaborationClinical Systems
About the role
Key responsibilities & impact- Oversee daily line management for assigned clinical operations staff
- Provide coaching, development support, resourcing, alignment, training, and professional development
- Collaborate with senior management and executive staff on strategic planning and business development
- Manage induction and orientation programs for new employees
- Maintain staff CVs, training records, position profiles, and experience profiles
- Support local resourcing and project/functional lead activities
- Escalate issues affecting project deliverables
- Deliver training on WPDs, SOPs, local requirements, and clinical operations topics
- Identify training gaps and support training program development
- Participate in process improvement initiatives
- Facilitate risk-based monitoring
- Alert management to quality issues, request QA audits, and support audit responses
- Review CTMS, Preclarus, and Clarity systems to evaluate metrics, KPIs, and project status
- Evaluate staff work and conduct remote or on-site PAVs
- Manage interviewing, selection, job descriptions, development, goal setting, performance management, coaching, counseling, and separations
- Review and approve time records, expense reports, leave requests, and overtime
- Manage client CTOS and site records coordination
- Plan, distribute, collect, and quality-check site records through the Site Collaboration tool
- Coordinate clinical trial regulatory tasks, materials, documentation, submissions, supplies, reporting, and stakeholder communication
- Maintain clinical systems and trial data tracking
- Support TMF completion and OMP milestones
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 0 to 5 years
- 1+ year of leadership responsibility
- Secondary education in Business Administration or equivalent
- 2 years of experience for Clinical Trial Operations Specialist responsibilities
- 0-1 year of experience for Site Records Coordinator responsibilities
- Understanding of Clinical Operations Landscape
- Understanding of Trial Master File
- Understanding of TMF Reference Model
- Understanding of Good Clinical Practice
- Good Documentation Practice
- Site Collaboration
- Understanding of tools and systems
- Understanding of CTMS
- Communication and stakeholder management
- Ability to travel domestically and internationally and frequently drive to site locations
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused workplace