Senior Clinical Trial Manager

Definium Therapeutics

. Provide site- and/or country-level clinical trial management and vendor/external service provider oversight .

Posted 10/23/2026full-timeRemote • United StatesSenior💰 $160,000 - $190,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive clinical trial management expertise, ensuring compliance with GCP/ICH guidelines and FDA regulations while overseeing vendor relationships and project execution. Proven ability to lead cross-functional teams, manage budgets, and maintain data integrity throughout the clinical trial process.

Highest-signal resume keywords

Clinical Trial ManagementVendor ManagementProject PlanningRegulatory ComplianceTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research Operational KnowledgeProtocol DevelopmentBudget ManagementData CollectionMonitoring GuidelinesECRF DesignSite AuditsClinical Trial ExecutionRisk ManagementPatient Enrollment

Soft Skills

Strong Organizational SkillsAttention to DetailEffective CommunicationPresentation SkillsTeam Productivity

Tools & Technologies

DefiniumCRO Systems

Industry Keywords

Life SciencesPharmaceutical IndustryClinical Study ReportSOPsGCPICH GuidelinesFDA RegulationsPsychiatric Space

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide site- and/or country-level clinical trial management and vendor/external service provider oversight
Serve as Clinical Operational Trial Lead when assigned, overseeing cross-functional delivery from protocol synopsis through Clinical Study Report and trial-results disclosure
Ensure high-quality deliverables within timelines, budget, SOPs, GCP/ICH guidelines, and applicable FDA and state regulations
Review monitoring visit reports, schedules, metrics, protocol deviations, issues, and action items using Definium or CRO systems
Serve as sponsor contact for vendors and oversee deliverables, patient enrollment, data collection, risks, timelines, and budgets
Maintain therapeutic knowledge and familiarity with clinical protocols and projects
Revise vendor scopes of service, budgets, plans, and timelines with CROs/vendors
Oversee CRO monitoring team activities and deliverables
Assist Quality Assurance with site audits
Review and contribute to protocols, eCRF designs, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study documents
Manage site contracts, budgets, vendor invoices, and accruals
Track and coordinate investigational product, clinical trial materials, and laboratory samples
Organize site round-table and recruitment meetings
Participate in departmental SOP, systems, and process development
Ensure external service provider selection and setup align with protocol requirements, budgets, and timelines
Maintain inspection readiness, data integrity, and overall data quality
Ensure trial-specific training for trial team members and CRO personnel

Requirements

What you’ll need

BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 6 years clinical trial experience in the pharmaceutical industry or CRO
Experience with managing clinical trials or prior experience in a senior CRA role, ideally in the psychiatric space
Willingness and ability to travel up to 20% of the time, defined by business needs
Strong organizational skills and attention to detail
Ability to work effectively in a fast-paced and dynamic environment
Clinical research operational knowledge
Project planning and management skills
Communication and presentation skills
Ability to manage all aspects of clinical trial execution
Experience managing teams in a virtual environment
Experience in vendor management strongly preferred
Excellent leadership skills and proven ability to foster team productivity and cohesiveness

Benefits

Comp & perks

100% paid health benefits including Medical, Dental and Vision for you and your dependents
401(k) program with company match and vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave
Fun fringe perks
Additional compensation, including bonus and equity, may be available