Position: Clinical Team Manager (CTM)
Job ID: R-01211806
Location: 2 Locations (Onsite)
Job Type: Full-Time
Category: Clinical Research
Company: PPD – Part of Thermo Fisher Scientific
About the Company
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a global impact.
Our mission is to enable our customers to make the world healthier, cleaner, and safer.
Through our PPD® clinical research portfolio, we conduct trials in over 100 countries, combining laboratory, digital, and decentralized clinical services to advance life-changing therapies.
We empower our colleagues with the resources to achieve individual goals while contributing to global health improvement.
Position Summary
The Clinical Team Manager (CTM) is responsible for overseeing all clinical operational and quality aspects of assigned studies (low to moderate complexity) in compliance with ICH-GCP guidelines and company standards.
The CTM ensures timely delivery of clinical milestones, including clean data from qualified patients, within the agreed contractual timelines, while maintaining quality, efficiency, and profitability.
This role involves leading a clinical team, coordinating study activities, managing timelines, and ensuring projects meet customer expectations on time, quality, and cost.
Key Responsibilities
Clinical Operations Management
Manage and oversee all clinical and quality aspects of assigned studies according to ICH-GCP and protocol requirements.
May assume Clinical Study Manager (CSM) duties for small or less complex projects.
Ensure all clinical deliverables are achieved within contract timelines and budgets.
Monitor study progress, timelines, and resources using appropriate tracking and management tools.
Conduct recovery actions when deviations occur and ensure timely query resolution and CRF collection.
Project Documentation & Tools
Develop essential clinical documentation such as:
Monitoring Plans
Supervision Plans
Data Quality Plans
Master Action Plans (MAP)
Ensure setup, organization, and quality of the Trial Master File (TMF) (local and central).
Contribute to the design of CRFs, informed consent forms, and other study-specific documents as needed.
Team Leadership & Communication
Lead and mentor the clinical study team, ensuring collaboration across departments.
Conduct team meetings to monitor progress, address challenges, and align objectives.
Train team members on standardized monitoring processes and corporate procedures.
Collaborate with the Project Manager to prepare for and present at client meetings (bid defense, hand-off, progress updates).
Monitoring & Site Oversight
Review monitoring visit reports and ensure issues are promptly resolved.
Conduct or co-monitor clinical trials to assess compliance and performance.
In smaller regions, perform Accompanied Field Visits (AFVs) and oversee project financials.
Engage with investigational sites on protocol adherence, patient enrollment, and CRF completion.
Start-Up & Regulatory Coordination
Oversee and coordinate start-up activities, ensuring timely ethics and regulatory submissions.
Review critical document quality for Regulatory Compliance Review.
Respond to ethics committee queries and ensure all questions are addressed promptly.
Resource & Financial Management
Forecast and manage clinical resources and assignments.
Evaluate workloads against project budgets, adjusting resources when necessary.
Provide input into clinical activity cost estimates and financial forecasting.
Education & Experience
Bachelor’s degree or equivalent qualification in a life science or related field.
Minimum 5 years of relevant clinical research experience, including project coordination or leadership.
Knowledge, Skills, and Abilities
Strong leadership, mentoring, and motivational abilities.
Excellent planning, prioritization, and organizational skills.
Solid interpersonal and problem-solving skills within a matrix or multicultural environment.
Ability to adapt to complex and changing project scenarios.
Comprehensive knowledge of clinical monitoring processes and ICH-GCP/FDA guidelines.
Sound decision-making and judgment skills.
Strong financial acumen, including budgeting and forecasting capabilities.
Proficiency in Microsoft Office (Word, Excel, Outlook) and related clinical systems.
Excellent written and verbal communication skills (English proficiency required).
Strong attention to detail and ability to balance quality with timelines.
Benefits
Competitive salary and annual incentive bonus.
Comprehensive healthcare and employee benefits.
Career growth and development opportunities within a global organization.
An innovative, inclusive, and performance-driven work culture based on:
Integrity
Intensity
Involvement
Innovation
Equal Opportunity Statement
Thermo Fisher Scientific is an EEO/Affirmative Action Employer.
We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.
Accessibility Support
Job seekers with disabilities who need accommodations during the application process can contact:
📞 1-855-471-2255
(Please include your contact information and specific accommodation details.)
Apply Now
Be part of a mission-driven organization where your leadership directly impacts global health outcomes.
👉 Apply today: jobs.thermofisher.com
#StartYourStory with PPD, part of Thermo Fisher Scientific.
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