Clinical Trial Manager/Senior Clinical Trial Manager
New
P
Precision for MedicineClinical research
Remote, United StatesFull-TimeSenior
Salary$110,700 — $200,900 USD
Apply NowOpens the employer's application page
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.
- Minimum of 7 years of clinical research experience or proven competencies for the position.
- Significant clinical monitoring experience.
- Experience with Microsoft Office Products, including Outlook, Word, Excel, and PowerPoint.
- Mastery of ICH-GCP, relevant SOPs, and regulatory guidance, with the ability to implement them.
- Direct work experience in a cross-functional environment.
- In-depth experience in pharmaceutical and/or device research.
- Experience in planning, risk management, and change management.
- Experience in functional management and delegation.
- Ability to travel domestically and internationally, including overnight stays.
- Advanced degree preferred.
- Experience with radiopharmaceuticals and/or CAR-T studies preferred.
Responsibilities
- Serve as the primary clinical point of contact with the client.
- Develop study clinical documents, training materials, and study-specific plans.
- Generate potential site lists and lead site feasibility and recruitment planning.
- Lead clinical team meetings and set expectations for CRAs and CTAs.
- Develop clinical monitoring strategies and use metrics to track study progress.
- Oversee regulatory submissions and approvals with regulatory departments.
- Manage eTMF implementation and management.
- Coordinate data quality, data cleaning timelines, investigational product processes, and vendor management.
- Support GCP audit preparation and CAPA development and implementation.
- Collaborate with project managers on budgets, resourcing, and project management responsibilities.
View Full Description & ApplyYou'll be redirected to the employer's site
