Clinical Trial Manager/Senior Clinical Trial Manager
New
P
Precision for MedicineClinical Research
Remote, United StatesFull-TimeSenior
Salary$110,700 — $200,900 USD
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Job Details
- Experience
- Minimum of 7 years of clinical research experience
- Required Skills
- Project ManagementMicrosoft OfficeBudget managementRisk Management
Requirements
- Bachelor’s degree or equivalent in a science or health-related field.
- Minimum of 7 years of clinical research experience.
- Significant prior clinical monitoring experience.
- Demonstrated mastery of ICH-GCP guidelines and regulatory requirements.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
- Proven experience in functional management, delegation, and risk management.
- Strong ability to lead and inspire excellence in a cross-functional team.
- Excellent communication, interpersonal, and presentation skills.
- Proven negotiation and conflict management strategies.
- Ability to travel domestically and internationally, including overnight stays.
- In-depth experience in pharmaceutical and/or device research.
Responsibilities
- Serve as the primary clinical point of contact with the client.
- Develop and finalize study-related clinical documents, including plans, manuals, and templates.
- Drive site feasibility processes, including identifying potential site lists and recruitment risks.
- Lead internal clinical team meetings and provide oversight for CRAs and CTAs.
- Oversee submissions and approvals to Competent Authorities and IRBs.
- Develop clinical monitoring strategies to ensure study timelines and quality deliverables.
- Manage eTMF implementation, drug accountability, and study budget variances.
- Collaborate with cross-functional teams to develop and implement CAPA plans.
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