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Senior Manager, Clinical Trial Management
Precision Medicine GroupSenior clinical trial manager overseeing pharmaceutical and device studies for Precision Medicine Group. Leading feasibility, monitoring, compliance, recruitment, vendors, and clinical teams remotely in the United States.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including planning, execution, and oversight of studies while ensuring compliance with ICH-GCP and regulatory standards. Proven ability to lead teams, manage budgets, and develop training materials to enhance clinical operations.
Highest-signal resume keywords
Clinical Trial ManagementICH-GCP MasteryClinical Monitoring ExperienceProject Management ResponsibilitiesNegotiation and Conflict Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Research ExperienceClinical Management TechniquesRisk ManagementChange ManagementClinical Data ReviewStudy-Related Document DevelopmentSite Feasibility AssessmentInvestigational Product AccountabilityMetrics ReportingBudget Management
Soft Skills
Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsAttention to DetailTime Management
Tools & Technologies
Microsoft Office ProductsElectronic Trial Master File (eTMF)
Industry Keywords
Pharmaceutical ResearchDevice ResearchGCP Audit PreparationRegulatory GuidanceClinical Vendor Management
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Serve as the clinical trial lead responsible for planning, conduct, and operational oversight of clinical studies
- Act as the primary clinical point of contact with the client
- Collaborate with the Project Manager on monthly invoicing and clinical budget variance management
- Develop study-related clinical documents, 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
- Identify enrollment risks and develop country recruitment and retention strategies
- Manage communications and relationships with investigators and study teams throughout feasibility, start-up, enrollment, maintenance, and close-out
- 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 to meet study timelines and quality deliverables
- Generate and use clinical metrics reporting to monitor study execution and communicate issues
- Implement and manage the electronic Trial Master File (eTMF)
- Collaborate on CAPA development, implementation, and closure
- Assist sites, staff, and CRAs with GCP audit preparation
- Support project-specific resourcing
- 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 responsibilities when a cross-functional Project Manager is not assigned
- Support business development and marketing activities
- Negotiate site budgets and investigator contracts when required
- Review site visit reports and ensure monitoring follows the monitoring plan
- Manage clinical vendors when required
- Perform clinical data review and query generation when required
- Potentially manage direct reports
- Perform other duties assigned by management
Requirements
What you’ll need- Bachelor’s degree or equivalent combination of education/experience in a science or health-related field
- Minimum 7 years of clinical research experience or proven competencies for the position, with significant clinical monitoring experience
- Experience with Microsoft Office Products, including Outlook, Word, Excel, and PowerPoint
- Advanced degree preferred
- Mastery of ICH-GCP, relevant Precision SOPs, and regulatory guidance
- Working knowledge of clinical management techniques and tools
- Direct experience in a cross-functional environment
- Proven functional management experience, including delegation and fostering cohesive team dynamics
- Proven experience in planning, risk management, and change management
- In-depth experience in pharmaceutical and/or device research
- Demonstrated successful independent negotiation and conflict management strategies
- Excellent communication, interpersonal, organizational, presentation, verbal, and written communication skills
- Attention to detail and customer service demeanor
- Ability to travel domestically and internationally, including overnight stays
- Excellent time management, negotiation, critical thinking, decision-making, and analytical skills
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
- Other benefits