Clinical Trial Manager – Jr./Lower Mid-Level

Location: Remote (East Coast candidates preferred) with a few days onsite in Chapel Hill, NC. Duration: 1 year with possible extension. Visa sponsorship available for US Citizens and Green Card holders.

About the Role

Seeking a Junior/Lower Mid-Level Clinical Trial Manager (CTM) to manage clinical operational and quality activities for low-to-moderate complexity clinical studies. The CTM will work as part of a team to ensure clinical deliverables are completed on time, within budget, and in compliance with ICH/GCP and applicable regulations.

Responsibilities

• Manage clinical operations for assigned studies in compliance with ICH/GCP.
• Develop Monitoring Plans, Monitoring Guidelines, and other clinical tools.
• Support development of the Master Action Plan (MAP).
• Maintain the Trial Master File (TMF) for quality, completeness, and timely filing.
• Monitor study timelines, metrics, monitoring visits, CRF collection, and query resolution.
• Coordinate with clinical sites regarding protocol, patient, and study-related issues.
• Lead or participate in clinical team meetings and cross-functional activities.
• Support study startup, ethics committee, and regulatory submissions.
• Review monitoring reports and implement recovery actions when needed.
• Support clinical resource planning, forecasting, budgeting, and timelines.
• Ensure clinical deliverables meet time, quality, cost, and contractual requirements.

Requirements

• Bachelor’s degree or equivalent.
• 5+ years of relevant clinical research or clinical operations experience.
• Clinical Trial Management or comparable clinical operations experience.
• Strong knowledge of ICH/GCP and FDA regulations.
• Experience with clinical monitoring, TMF, study documentation, and site management.
• Strong organizational, communication, problem-solving, and leadership skills.
• Proficiency with Excel, Word, Outlook, and clinical systems.
• Ability to work effectively in a remote, matrixed environment.

Submission Requirements

• Must provide a photo ID.
• Month and day of birth.
• Valid U.S. permanent address.
• Two or three references from previous managers with company email addresses.

Ideal Candidate

Clinical Trial Manager, Clinical Study Manager, or experienced Senior CRA with strong clinical operations, monitoring, TMF, ICH/GCP, and study management experience.