Clinical Trial Manager / Senior Clinical Trial Manager
New
Based in the 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 in a scientific, healthcare, or related discipline; advanced degree preferred.
- Minimum of 7 years of clinical research experience, including significant clinical monitoring and trial management.
- Strong knowledge of ICH-GCP principles, regulatory requirements, and clinical operations processes.
- Demonstrated experience managing complex pharmaceutical and/or medical device clinical studies.
- Proven ability to lead cross-functional teams and create a collaborative working environment.
- Experience with clinical project planning, risk management, change management, and operational strategy development.
- Strong organizational skills with exceptional attention to detail.
- Excellent communication, presentation, negotiation, and conflict management skills.
- Proficiency with Microsoft Office applications including Outlook, Word, Excel, and PowerPoint.
- Ability and willingness to travel domestically and internationally.
Responsibilities
- Serve as the primary clinical point of contact for clients and provide strategic oversight throughout the lifecycle of assigned clinical studies.
- Plan, coordinate, and oversee clinical trial operations to ensure studies are conducted according to protocols, SOPs, ICH-GCP guidelines, and applicable regulatory requirements.
- Develop and manage key clinical documents, including clinical plans, informed consent templates, study-specific forms, manuals, trackers, training materials, and monitoring guidance.
- Partner with project management teams on budget oversight, invoicing, resource planning, and risk management activities.
- Lead site feasibility, recruitment, and retention strategies by collaborating with stakeholders to identify opportunities and address enrollment risks.
- Lead clinical team meetings, provide guidance to clinical staff, and support CRA and vendor training initiatives.
- Oversee site activation, monitoring activities, regulatory submissions, ethics committee approvals, and study closeout processes.
- Manage eTMF implementation and oversight while ensuring documentation quality and inspection readiness.
- Support business development initiatives and contribute clinical expertise to proposals and client-facing activities.
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