Clinical Trial Manager – Senior Clinical Trial Manager

Precision For Medicine

. Serve as the clinical trial lead responsible for planning, conduct, and oversight of the operational portion of clinical studies .

Posted 10/28/2026full-timeRemote • United StatesSenior💰 $110,700 - $200,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical trial management, including planning, oversight, and compliance with ICH-GCP and regulatory requirements. Proven ability to lead teams, manage clinical budgets, and develop training materials while ensuring data quality and effective communication.

Highest-signal resume keywords

Clinical Trial ManagementICH-GCP ComplianceClinical Monitoring ExperienceBudget ManagementTraining Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceClinical Management TechniquesData Quality ManagementMetric ReportingCAPA DevelopmentInvestigational Product AccountabilitySite Feasibility AssessmentRegulatory SubmissionsClinical Document DevelopmentNegotiation Skills

Soft Skills

Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsAttention to DetailCustomer Service Demeanor

Tools & Technologies

Microsoft Office ProductsCTMSETMF

Industry Keywords

Clinical StudiesSOPsRegulatory RequirementsPharmaceutical ResearchDevice ResearchCross-Functional EnvironmentRisk ManagementChange Management

About the role

Key responsibilities & impact

Serve as the clinical trial lead responsible for planning, conduct, and oversight of the operational portion of clinical studies
Ensure clinical studies comply with protocols, SOPs, ICH-GCP, and applicable regulatory requirements
Act as the primary clinical point of contact with the client
Collaborate with the PM on monthly invoicing and clinical budget variance management
Develop clinical documents, study plans, forms, manuals, guidelines, trackers, slides, and training materials
Identify training needs for CRAs and third-party vendors and present training at investigator and study kick-off meetings
Generate potential site lists and drive site feasibility
Develop country recruitment and retention strategies
Coordinate feasibility, site start-up, enrollment, maintenance, and close-out procedures
Lead internal clinical team meetings and set expectations for CRAs and CTAs
Address CRA and site questions and maintain FAQ logs
Support investigator meetings
Review or approve investigational product release packages
Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
Develop clinical monitoring strategies and track study timelines and quality deliverables
Generate and use metric reporting, including CTMS, DM query trends, and outstanding monitoring reports
Implement and manage the eTMF
Develop and implement CAPA plans with PM, CRAs, and QA
Assist sites, staff, and CRAs with GCP audit preparation
Escalate CRA performance and site compliance issues
Collaborate with data management and CRAs to ensure data quality and cleaning timelines
Manage investigational product accountability and reconciliation
Assume project management responsibility when a cross-functional PM is not assigned
Support business development and marketing activities
Negotiate site budgets and investigator contracts as needed
Review site visit reports and ensure monitoring follows the monitoring plan
Manage clinical vendors as needed
Perform clinical data review and query generation as needed
May have line management responsibilities

Requirements

What you’ll need

Bachelor’s degree or equivalent combination of education/experience in science or health-related field
Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
Excellent communication and interpersonal skills to effectively interface with others in a team setting
Excellent organizational skills, attention to detail, and a customer service demeanor
Ability to travel domestically and internationally including overnight stays
Mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance
Working knowledge of clinical management techniques and tools
Direct work experience in a cross-functional environment
Proven experience in functional management, planning, risk management, and change management
In-depth proven experience in pharmaceutical and/or device research required
Demonstrated successful independent negotiation and conflict management strategies
Candidates must be legally authorized to work in the country of employment without employer sponsorship

Benefits

Comp & perks

Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation