Job Title: Clinical Trial Manager (CTM) – Atopic Dermatitis (Dermatology Experience Required)
Job ID: R-01329657
Category: Clinical Research
Job Type: Full-time
Work Location: Fully Remote (North Carolina, United States)
Work Schedule: Standard (Monday–Friday)
Work Environment: Office
About the Organization
At Thermo Fisher Scientific, you’ll discover meaningful work that contributes to improving global health outcomes. As part of the PPD® Clinical Research portfolio, we drive research and development across laboratory, digital, and decentralized trial services. With clinical trials conducted in over 100 countries, our mission is to enable customers to make the world healthier, cleaner, and safer.
About the Department
Our Global Clinical Operations team within PPD® Clinical Research Services provides comprehensive end-to-end clinical trial support — from study start-up and monitoring through to close-out. We deliver high-quality, cost-efficient, and timely clinical studies across commercial and government sectors.
The PPD FSP (Functional Service Provider) Model
The PPD FSP division partners directly with clients as an extension of their teams, providing flexible, high-performing operational support. FSP professionals work with leading sponsors while benefiting from the structure and resources of the PPD CRO — ensuring excellence, consistency, and scalability across global clinical programs.
Role Summary
The Clinical Trial Manager (CTM) provides cross-functional leadership and global accountability for all operational deliverables of assigned clinical studies — from final protocol concept to clinical study report (CSR) and results disclosure.
This position demands a strong operational mindset, strategic thinking, and expertise in dermatology, particularly Atopic Dermatitis. The CTM ensures delivery of trials on time, within budget, and in full compliance with SOPs, ICH-GCP, and regulatory standards.
Key Responsibilities
1. Study Leadership & Oversight
Lead global clinical trials, ensuring delivery within defined timelines, budget, and quality standards.
Develop and refine study timelines and budgets using internal and external benchmarks.
Oversee cross-functional planning, study progress tracking, and completion of deliverables.
Lead, mentor, and support junior clinical staff.
2. Vendor & CRO Management
Guide and monitor CROs and external vendors to ensure all contractual obligations and KPIs are met.
Evaluate performance metrics, resolve issues proactively, and ensure on-time deliverables.
3. Clinical Trial Documentation
Develop key clinical tools, including Monitoring Plans, Guidelines, and Data Quality Plans.
Contribute to creation and management of the Master Action Plan (MAP) and Trial Master File (TMF).
Participate in the design of CRFs, informed consent forms, and other trial-specific documents.
Ensure document quality and compliance with regulatory and SOP requirements.
4. Cross-Functional Collaboration
Partner with project managers to support client meetings, bid defenses, and project hand-offs.
Collaborate with data management, biostatistics, regulatory, and clinical teams to ensure cohesive project execution.
Conduct regular team meetings to track timelines, resolve challenges, and maintain communication across stakeholders.
5. Quality, Compliance & Monitoring
Implement and train teams on standardized monitoring processes aligned with corporate policies.
Monitor site performance, oversee clinical data collection, and ensure proper documentation.
Conduct or accompany field visits (as required) to assess monitoring quality and trial compliance.
Ensure timely study closure, document archiving, and audit readiness.
6. Financial & Resource Management
Manage project financials, clinical budgets, and forecasting.
Monitor resource allocation, identify capacity gaps, and ensure cost-effective operations.
Provide input into future budget estimates and client proposals.
Education & Experience
Education:
Bachelor’s degree (or equivalent) in life sciences, pharmacy, nursing, or related field.
Experience:
Minimum 3+ years of experience in clinical trial management, monitoring, or equivalent roles.
Experience in Dermatology / Atopic Dermatitis is mandatory.
Prior experience managing global Phase I–IV clinical trials preferred.
CRO or sponsor-side leadership experience highly desirable.
Knowledge, Skills, and Abilities (KSAs)
Strong leadership, mentoring, and team integration skills.
Excellent planning and organizational abilities; capable of managing multiple priorities.
Solid interpersonal and cross-cultural communication skills.
Strong problem-solving, judgment, and decision-making capabilities.
In-depth understanding of ICH-GCP, FDA, and other regulatory guidelines.
Proficiency in MS Office (Word, Excel, Outlook, PowerPoint).
Solid understanding of clinical monitoring practices and quality standards.
Financial acumen — budgeting, forecasting, and fiscal oversight.
Fluent in English (written and spoken).
Adaptability to changing environments and complex project demands.
Travel Requirements
10%–20% travel, including potential domestic and international site visits.
Key Attributes for Success
Strategic operational mindset.
Collaborative leadership style.
Commitment to quality, integrity, and innovation.
Curiosity for data-driven and technology-enabled solutions.
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