Clinical Trial Manager / Senior Clinical Trial Manager
New
P
Precision Medicine GroupClinical 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 OfficeRisk 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 with significant clinical monitoring experience.
- In-depth experience in pharmaceutical and/or device research.
- Mastery knowledge of ICH-GCP, standard operating procedures, and regulatory guidance.
- Proven experience in functional management, planning, risk management, and change management.
- Ability to lead and inspire excellence within a cross-functional team environment.
- Proficiency in Microsoft Office products including Outlook, Word, Excel, and PowerPoint.
- Excellent organizational, communication, and negotiation skills.
- Ability to travel domestically and internationally including overnight stays.
Responsibilities
- Serve as the primary clinical point of contact with the client.
- Develop study-related clinical documents such as clinical plans, Informed Consent Form templates, and study trackers.
- Manage site feasibility, selection, and start-up processes.
- Lead internal clinical team meetings and set expectations for CRAs and CTAs.
- Develop clinical monitoring strategies to ensure study timelines and quality deliverables are met.
- Oversee eTMF implementation and management.
- Collaborate with PM, CRAs, and QA to develop and close out CAPA plans.
- Ensure data quality and compliance with data cleaning timelines in coordination with data management teams.
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