Clinical Trial Manager – FSP

Thermo Fisher Scientific

Clinical Trial Manager overseeing clinical studies and regulatory deliverables for Thermo Fisher Scientific, a global science-services company. Managing monitoring, documentation, timelines, resources, and client coordination.

Posted 8/18/2026full-timeRemote • Rhode Island • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical operations and quality for low- to moderate-complexity studies, ensuring compliance with ICH GCP and regulatory requirements. Proficient in developing clinical tools, managing study start-up activities, and effectively communicating with stakeholders to achieve project deliverables.

Highest-signal resume keywords

Clinical Operations ManagementStudy Start-Up ExperienceRegulatory Submissions KnowledgeClinical Monitoring PracticesFinancial Acumen

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementMonitoring Plans DevelopmentCRF Design and DevelopmentRegulatory ComplianceBudgeting and ForecastingData Quality Plan ImplementationTrial Master File ManagementStudy Protocol DevelopmentMetrics MonitoringOncology Experience

Soft Skills

Effective CommunicationProblem-SolvingOrganizational SkillsInterpersonal SkillsDecision-Making

Tools & Technologies

OutlookExcelWord

Industry Keywords

ICH GCPFDA GuidelinesClinical MonitoringEthics CommitteeInvestigator Site Contracts

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage all clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan
Contribute to the Master Action Plan for clinical-related documents
Ensure timely setup, organization, content, and quality of relevant Trial Master File sections
Participate in designing and developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Collaborate with the project manager to prepare, organize, and present client meetings, including bid defense and hand-off meetings
Collaborate with clinical and other departmental teams to meet project deliverables
Communicate regularly with the team and lead team meetings to maintain timelines, resources, interactions, and quality
Implement and train standardized clinical monitoring processes
Archive documents and study materials in a timely manner
Achieve final clinical deliverables within contractual timelines by monitoring activity timelines and metrics, providing status updates, reviewing projects, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution
Monitor or co-monitor clinical trials to assess performance and meet contractual obligations
Conduct Accompanied Field Visits and manage project financials in smaller regions
Communicate with study sites about protocol, patient participation, case report forms, and study-related issues
Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions
Ensure essential document quality meets Regulatory Compliance Review expectations
Review and follow up on ethics committee questions
Provide input into clinical activity forecasts
Manage clinical resources, delegate responsibilities, and identify additional resource requirements

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
5+ years of comparable experience
Experience managing multiple studies and competing priorities simultaneously
Strong knowledge of Australia's study start-up process, regulatory submissions, and investigator site contracts and budgets
Familiarity with clinical monitoring practices, processes, and requirements
Understanding of relevant regulations, including ICH/GCP and FDA guidelines
English language proficiency
Effective oral and written communication skills
Good computer skills with Outlook, Excel, Word, and similar applications
Financial acumen and knowledge of budgeting, forecasting, and fiscal management
Planning, organizational, interpersonal, problem-solving, judgment, and decision-making skills
Ability to work effectively in a changing environment with complex or ambiguous situations
Oncology experience considered advantageous
Study start-up experience within Australia considered an asset

Benefits

Comp & perks

Comprehensive benefits
Wellness programs
Employee Assistance Program providing confidential support for personal and work-related issues
Flexible arrangements
Generous leave policies
Option to purchase additional leave
Paid birthday leave
Company paid parental leave
Paid volunteer time
Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning
Workshops
Mentorship programs