Clinical Study Manager

About the role

Clinical Study Manager will support day-to-day clinical trial execution, including study coordination, site and vendor oversight, metric tracking, TMF/inspection readiness, and cross-functional collaboration to help advance Aurion Biotech’s clinical programs.

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

Qualifications

• Bachelor’s degree in life sciences, nursing, or related field
• 2-4 years of experience in clinical research, including exposure to clinical trial operations, either in a sponsor, CRO, or academic setting supporting Phase 2 or 3 clinical trials
• Familiarity with study start-up, site maintenance, closeout, and inspection readiness processes
• Working knowledge of ICH/GCP guidelines and clinical trial processes
• Strong organizational and time management skills; detail-oriented and able to manage multiple tasks
• Proficient in Microsoft Office (Word, Excel, PowerPoint); experience with Canva, CTMS, TMF, EDC, and other clinical trial systems a plus
• Strong interpersonal and communication skills, both written and verbal

Required skills and abilities

• Ability to work effectively in a team environment and across global teams and vendors
• Excellent written, verbal, and interpersonal communication skills; ability to communicate with impact across diverse internal and external stakeholders
• Demonstrated cultural agility, integrity, and a passion for advancing transformative science
• Ability to travel up to 15%
• A strong alignment with, and commitment to, Aurion Biotech’s mission, vision, and core values