Clinical Trial Manager/Senior Clinical Trial Manager

Precision Medicine Group

. 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 expertise 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 high-quality deliverables.

Highest-signal resume keywords

Clinical Trial ManagementICH-GCP ComplianceClinical Monitoring ExperienceProject ManagementNegotiation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchRisk ManagementChange ManagementClinical Data ReviewSite Feasibility AssessmentTraining DevelopmentMetrics GenerationInvestigational Product AccountabilityBudget ManagementRegulatory Submissions

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational SkillsAttention to DetailCustomer Service Demeanor

Tools & Technologies

Microsoft Office ProductsCTMSETMF

Industry Keywords

Clinical StudiesPharmaceutical ResearchDevice ResearchRadiopharmaceuticalsCAR-T Studies

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 studies comply with protocols, SOPs, ICH-GCP, and applicable regulatory requirements
Act as primary clinical point of contact with the client
Collaborate with the Project Manager on monthly invoicing and clinical budget variance management
Develop clinical documents, study forms, manuals, trackers, training materials, and CRF completion guidelines
Identify and develop training needs for CRAs and third-party vendors; present at Investigator and Study Kick-off meetings
Generate potential site lists and drive site feasibility
Identify enrollment risks and develop country recruitment/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 and review/approve IP 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 metrics from CTMS, DM query trends, and outstanding monitoring reports
Implement and manage the eTMF
Collaborate on CAPA development, implementation, and closure
Assist sites, staff, and CRAs with GCP audit preparation
Coordinate resourcing issues, escalate performance/compliance issues, and support data quality
Manage investigational product accountability and reconciliation
Assume project management responsibilities 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 plan execution
Manage clinical vendors as needed
Perform clinical data review and query generation as needed
May have line management responsibilities
Perform other duties assigned by management

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 and delegation
Proven experience in planning, risk management and change management
In-depth proven experience in pharmaceutical and/or device research
Demonstrated successful independent negotiation and conflict management strategies
Advanced degree preferred
Experience with Radiopharmaceuticals and/or CAR-T studies preferred

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