Clinical Trial Manager / Senior Clinical Trial Manager
New
P
Precision Medicine GroupClinical Research
Remote, United StatesFull-TimeSenior
Salary110,700 - 200,900 USD per year
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Job Details
- Experience
- Minimum of 7 years of clinical research experience
- Required Skills
- Project ManagementRisk 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
- Experience with Microsoft Office Products
- Mastery knowledge of ICH-GCP and regulatory guidance
- Direct work experience in a cross-functional environment
- Proven experience in functional management, planning, risk management, and change management
- Excellent communication and interpersonal skills
- Ability to travel domestically and internationally
Responsibilities
- Primary clinical point of contact with the client
- 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 country recruitment/retention strategy
- Lead internal clinical team meetings and set expectations for clinical team
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees
- Develop clinical monitoring strategies
- Responsible for eTMF implementation and management
- Collaborate with data management and CRAs to ensure data quality and compliance
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