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Ctm - Atopic Dermatitis (Dermatology) Experience Required

3+ years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trial Manager – Atopic Dermatitis (Dermatology) Experience Required
Location: Remote, North Carolina, United States
Job ID: R-01329657
Job Type: Full Time
Category: Clinical Research
Work Model: Fully Remote

Role Overview
Thermo Fisher Scientific is seeking an experienced Clinical Trial Manager (CTL) with a strong background in atopic dermatitis and dermatology clinical research. This role provides global operational leadership across clinical trials from study planning to closeout, ensuring compliance with regulatory standards, ICH/GCP guidelines, and internal SOPs. The position sits within the PPD clinical research portfolio, supporting both commercial and government programs.

The CTL will lead cross-functional teams, oversee CRO performance, coordinate global trial execution, and drive operational excellence across multiple stages of drug development. This role is ideal for candidates with proven leadership in dermatology studies, particularly atopic dermatitis.

Work Schedule
Standard Monday to Friday, remote office-based work.

Key Responsibilities

Clinical Trial Leadership and Oversight
• Lead global clinical trials from protocol finalization to delivery of the Clinical Study Report
• Establish, monitor, and refine study timelines and budget using internal and external benchmarks
• Oversee CROs and external vendors to ensure delivery against scope and contractual expectations
• Create and implement clinical tools including Monitoring Plans and Monitoring Guidelines
• Maintain Trial Master File quality and ensure documentation is organized and compliant
• Participate in CRF design, informed consent development, and study-specific documentation
• Lead and facilitate cross-functional study team meetings and ensure effective communication
• Collaborate with project managers on study updates, milestone planning, bid defenses, and client interactions
• Support development and implementation of monitoring processes aligned with corporate standards
• Monitor clinical trial progress, metrics, timelines, and quality indicators
• Review monitoring visit reports and oversee data verification, query resolution, and site engagement
• Coordinate ethics committee submissions and regulatory communications as needed
• Ensure essential documents meet regulatory compliance expectations
• Support resource planning, assignment of responsibilities, and identification of resource gaps

Operational and Vendor Management
• Continuously monitor vendor performance and escalate operational risks when needed
• Provide training, coaching, and oversight to junior team members
• Conduct accompanied field visits and perform co-monitoring when required
• Provide clinical insights during startup, feasibility, site selection, and forecasting activities

Experience and Education Requirements

Education
• Bachelor’s degree or equivalent in a scientific, healthcare, or related discipline

Experience Required
• Minimum 3 years of experience in clinical research, including site monitoring responsibilities
• Proven experience managing global clinical trials across phases I–IV
• Mandatory experience in atopic dermatitis or dermatology clinical studies
• Experience in CRO oversight, feasibility assessments, study startup, execution, and closeout
• Experience working in dynamic environments with evolving project demands
• Equivalent combinations of education, training, and relevant experience may be considered

Knowledge, Skills, and Abilities
• Strong leadership and mentoring skills with the ability to motivate and guide teams
• Excellent planning, organizational, and prioritization capabilities
• Strong problem-solving skills and ability to work within a multicultural matrix environment
• Effective written and verbal communication skills, including professional English proficiency
• Familiarity with clinical monitoring practices and regulatory requirements
• Ability to analyze workloads, budgets, forecasts, and resource allocation
• Solid financial acumen with understanding of project fiscal management
• Strong attention to detail with consistent accuracy
• Proficiency with computerized applications including Outlook, Word, Excel, and clinical platforms
• Working knowledge of ICH-GCP, FDA guidelines, and global regulatory expectations
• Ability to adapt to complex and changing environments
• Travel availability: 10–20 percent

Benefits
Thermo Fisher Scientific offers competitive compensation, annual incentive plans, healthcare coverage, and extensive professional development opportunities. Employees benefit from a culture centered around integrity, innovation, involvement, and continuous scientific advancement.