Clinical Trial Manager / Senior Clinical Trial Manager
New
P
Precision for MedicineClinical Research
Remote, United StatesFull-TimeManager
Salary110,700 - 200,900 USD per year
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Job Details
- Experience
- Minimum of 7 years of clinical research experience
- Required Skills
- Microsoft OfficeRisk ManagementStakeholder management
Requirements
- Bachelor’s degree or equivalent in science or health-related field
- Minimum of 7 years of clinical research experience
- Significant clinical monitoring experience
- Expertise in ICH-GCP and regulatory guidance
- Proven experience in functional management and delegation
- Experience in planning, risk management and change management
- Experience in pharmaceutical and/or device research
- Proficiency with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Ability to travel domestically and internationally
Responsibilities
- Primary clinical point of contact with the client
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents
- Identify and develop training needs for CRAs and third-party vendors
- Generate potential site list and drive site feasibility process
- Develop and finalize the country recruitment/retention strategy
- Lead internal clinical team meetings and sets expectations for clinical team
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees
- Responsible for eTMF implementation and management
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