Remote Clinical Study Manager

Aurion Biotech Inc.; United States; On-site; USD 95,000 - 113,000; Full time

Benefits offered by this job

Full health insurance

401(k) matching

EAP

FSA

Generous PTO

Paid parking

In-office catered lunches

Job summary

Aurion Biotech Inc. is hiring a Clinical Study Manager to support day-to-day clinical trial execution from a fully remote US-based role. You will coordinate studies across phases, oversee sites and vendors, track metrics, and contribute to TMF readiness while ensuring GCP/ICH compliance.

The ideal candidate has 2–4 years in clinical research, strong organizational and communication skills, and experience with CTMS/EDC/TMF; willingness to travel up to 15% as needed.

Qualifications

• Bachelor’s degree in life sciences, nursing, or related field.
• 2–4 years of clinical research experience supporting Phase 2 or 3 trials.
• Familiarity with study start-up, site maintenance, closeout, and inspection readiness.
• Working knowledge of ICH/GCP guidelines and trial processes.
• Strong organizational and time management skills; detail-oriented.
• Proficient in Microsoft Office; CTMS, TMF, EDC experience a plus.

Responsibilities

• Support clinical trial teams by assisting with the operational aspects of studies across all trial phases (start-up, conduct, and close-out) for insourced and outsourced clinical trials.
• Support procurement activities for clinical operations including vendor contracts, purchase orders.
• Support management of clinical supplies and clinical trial equipment provision and reclamation.
• Support the management of study-level documents in the Trial Master File (TMF) and TMF audits, as requested.
• Generate reports from EDC, CTMS, and 3rd party vendor portals.
• Generate newsletters, newsblasts, checklists and other site-level communications.
• Track and manage study data and metrics.
• Support the management of data quality and site performance metrics, including query resolution and database lock readiness.
• Support inspection readiness activities including site or study related audits, audit report finalization, audit findings and CAPAs.
• Collaborate with internal clinical operations team and cross-functional departments (Regulatory, Quality, Medical, CMC).
• Support Study Leads with vendor and system onboarding, including training coordination and process documentation.
• May support the conduct monitoring quality oversight and site engagement visits.
• Ensure compliance with GCP, ICH, Aurion SOPs, and CRO SOPs.
• Perform other duties as assigned.

Skills

Organizational skills

Communication skills

Cross-functional collaboration

Travel ability

Attention to detail

MS Office proficiency

Education

Bachelor's degree in life sciences or related field

Tools

CTMS

TMF

EDC

Microsoft Office

Canva

Job description

Aurion Biotech Inc. is hiring a Clinical Study Manager to support day-to-day clinical trial execution from a fully remote US-based role. You will coordinate studies across phases, oversee sites and vendors, track metrics, and contribute to TMF readiness while ensuring GCP/ICH compliance.

The ideal candidate has 2–4 years in clinical research, strong organizational and communication skills, and experience with CTMS/EDC/TMF; willingness to travel up to 15% as needed.