Clinical Study Manager

JOB TITLE: Clinical Study Manager

LOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY or WA.

REPORTS TO: Director, Clinical Trial Management

SALARY RANGE: $95,000 to $113,000

ABOUT THE POSITION

Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. Our lead candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and has advanced into Phase 3 clinical trials in 2026. Aurion operates as a separate entity with full support from Alcon. 

The 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.  

KEY 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

ABOUT AURION BIOTECH 

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values: 

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company. 
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate. 
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments. 

Aurion Biotech has a lot to accomplish in the next few years, and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com.

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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%, candidates local to an office may be asked to periodically travel to the office for meetings or clinical operations department support
• A strong alignment with, and commitment to, Aurion Biotech’s mission, vision, and core values.