Clinical Study Manager

This is a fully remote position, open to applicants in Kentucky, +11 more states.

📋 Description

• Assist clinical trial teams with the operational elements of studies throughout the start-up, execution, and close-out phases for both insourced and outsourced trials.

• Aid in procurement tasks, which include vendor contracts and purchase order management.

• Oversee the management of clinical supplies and the provision and reclamation of clinical trial equipment.

• Organize study-level documentation within the Trial Master File (TMF) and assist with TMF audits.

• Create reports utilizing EDC, CTMS, and third-party vendor portals.

• Develop newsletters, news blasts, checklists, and other communications for site-level dissemination.

• Monitor and manage study data and relevant metrics.

• Contribute to data quality efforts and site performance metrics, including resolving queries and preparing for database lock readiness.

• Assist with activities related to inspection readiness, audits, finalizing audit reports, addressing findings, and implementing CAPAs.

• Collaborate with teams from Clinical Operations, Regulatory, Quality, Medical, and CMC.

• Support Study Leads with onboarding vendors and systems, coordinating training, and documenting processes.

• May provide support for monitoring quality oversight and conducting site engagement visits.

• Ensure adherence to GCP, ICH, Aurion SOPs, and CRO SOPs.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's degree in life sciences, nursing, or a related discipline.

• 2–4 years of experience in clinical research, including involvement in clinical trial operations within a sponsor, CRO, or academic environment.

• Experience in supporting Phase 2 or 3 clinical trials.

• Familiarity with processes related to study start-up, site maintenance, closeout, and inspection readiness.

• Working knowledge of ICH/GCP guidelines and clinical trial procedures.

• Strong organizational and time management abilities; detail-oriented and capable of managing multiple tasks simultaneously.

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

• Experience with tools such as Canva, CTMS, TMF, EDC, and other clinical trial systems is advantageous.

• Excellent written, verbal, and interpersonal communication skills.

• Ability to collaborate effectively within a team and across global teams and vendors.

• Demonstrated cultural agility and integrity, with a passion for promoting transformative science.

• Willingness to travel up to 15%.

• Commitment to the mission, vision, and core values of Aurion Biotech.

• Candidates must reside in WA, MA, IN, NC, NJ, NH, NM, NY, PA, SC, SD, TX, or KY.

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching program.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous paid time off (PTO).

• Paid parking facilities.

• Subsidized commuter passes.

• In-office catered lunches.

• Team-building events.

• Community engagement projects.

• Competitive compensation packages.