Senior Clinical Trial Manager – Contract

4D Molecular Therapeutics

. Oversee and manage day-to-day operations of multiple Phase 1–3 clinical trials, including trial start-up, conduct, and close-out .

Posted 11/9/2026contractRemote • United StatesSenior💰 $84 - $98 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive clinical research knowledge and proven leadership in managing Phase 1–3 clinical trials, ensuring compliance with ICH GCP and regulatory requirements while effectively collaborating with cross-functional teams and external partners.

Highest-signal resume keywords

Clinical Trial ManagementGCP ComplianceProtocol ExecutionRisk Mitigation StrategiesLeadership in Clinical Research

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceTrial Plan DevelopmentDatabase Lock ManagementClinical Study Data AnalysisAudit ReadinessVendor ManagementClinical Supply ForecastingProtocol Deviation TrackingMonitoring Plan DevelopmentStudy Metrics Reporting

Soft Skills

Excellent Communication SkillsCreative Problem-SolvingConflict ResolutionOrganizational SkillsNegotiation Skills

Tools & Technologies

Microsoft Office SuiteMS ProjectTrial Master File ManagementClinical Study ReportsInformed Consent Forms

Industry Keywords

ICH GuidelinesBiotech IndustryClinical OperationsRegulatory FrameworkCross-Functional Collaboration

About the role

Key responsibilities & impact

Oversee and manage day-to-day operations of multiple Phase 1–3 clinical trials, including trial start-up, conduct, and close-out
Manage protocol execution and oversee CROs, study service providers, and consultants
Establish study milestones and track and report study metrics and timelines to leadership
Ensure trials comply with ICH GCP, regulations, protocols, and company SOPs
Prepare and review protocols, informed consent forms, pharmacy and laboratory manuals, monitoring plans, project plans, CRFs, vendor management plans, clinical study reports, and other study documents
Develop internal tracking and reporting tools and facilitate internal project team meetings
Support Trial Master File management and inspection readiness
Coordinate resolution of audit findings and maintain audit-ready clinical trial documentation
Identify, mitigate, and manage risks, including issue review, escalation, trend analysis, and prevention
Support selection and study-specific training of CRO staff, monitors, investigational sites, and service providers
Facilitate study start-up with CROs and clinical sites, including source document worksheets, CRF specifications, clinical site agreements, and other documentation
Assist with database lock, clinical study data analyses, and clinical study reports
Ensure timely responses to queries and monitoring discrepancies
Aid in planning and execution of investigator meetings
Participate in cross-functional study execution team meetings
Conduct or coordinate clinical site, CRO, and vendor monitoring and co-monitoring visits
Oversee outsourced monitoring and resolve site-related issues
Track and review protocol deviations and assess impact on study data
Oversee clinical supply forecasting for study drug and other supplies
May manage or oversee junior Clinical Operations staff
May support Clinical SOP development and department initiatives
Travel as needed to sites, conferences, and industry meetings

Requirements

What you’ll need

B.A./B.S. degree
7+ years of clinical research experience within the biotech or a similar industry
Experience developing trial plans, including creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management
Understanding of, and experience with, the regulatory framework applicable to interactions with HCPs, payers, advocacy groups, and other business partners
Proven leadership skills to direct protocol execution and ensure timeline, budget, and quality metrics are met
Excellent communication skills
Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
Excellent organizational, conflict resolution, prioritization, and negotiation skills
Proven ability in creative problem-solving and exercising sound judgment
Ability to collaborate effectively with study teams, cross-functional team members, and external partners
Ability to handle a high volume of highly complex tasks within a given timeline
Proficient computer skills, specifically Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook
Working knowledge of MS Project for developing and updating clinical study timelines
Ability to travel as needed to sites, conferences, and industry meetings
Sedentary work and repetitive wrist, hand, and finger motions; frequent speaking
Must follow applicable company, protocol, regulatory, and ICH GCP requirements

Benefits

Comp & perks

Career development opportunities
Internal training and external conference attendance
Equal employment opportunities
20% travel