Clinical Trial Manager/Senior Clinical Trial Manager
New
P
Precision for MedicineClinical research
Remote, United StatesFull-TimeSenior
SalaryReasonable estimate of the current range $110,700 — $200,900 USD
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Job Details
- Experience
- Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
- Required Skills
- Microsoft OfficeChange ManagementRisk Management
Requirements
- Bachelor’s degree or equivalent combination of education and experience in a science or health-related field.
- At least 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.
- Mastery of ICH-GCP, relevant SOPs, and regulatory guidance.
- In-depth experience in pharmaceutical and/or device research.
- Direct experience working in a cross-functional environment.
- Experience in functional management, delegation, and fostering cohesive team dynamics.
- Experience in planning, risk management, and change management.
- Ability to negotiate independently and manage conflict.
- Ability to travel domestically and internationally, including overnight stays.
- Advanced degree preferred.
- Experience with radiopharmaceuticals and/or CAR-T studies preferred.
Responsibilities
- Lead operational planning, conduct, and oversight of clinical studies in accordance with protocols, SOPs, ICH-GCP, and applicable regulatory requirements.
- Serve as the primary clinical point of contact with clients and collaborate with project managers on clinical budgets, invoicing, and resourcing.
- Develop study documents, training materials, and training plans for CRAs and third-party vendors.
- Generate potential site lists, lead feasibility, assess enrollment risks, and develop country recruitment and retention strategies.
- Coordinate communication with investigators and study teams across feasibility, site start-up, enrollment, maintenance, and close-out.
- Lead clinical team meetings, set expectations for CRAs and CTAs, and address CRA and site questions.
- Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees, and manage eTMF implementation and maintenance.
- Develop clinical monitoring strategies and use study metrics to track timelines, quality, and study performance.
- Collaborate with project managers, CRAs, and QA on CAPAs and support sites and staff in preparing for GCP audits.
- Coordinate data quality, investigational product accountability, and clinical vendor management.
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