Senior Manager, Clinical Trial Management
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Job Description
Senior 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.
Responsibilities:
- 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:
- 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:
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
- Other benefits
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