Clinical Trial Manager

JOB TITLE: Clinical Trial Manager

LOCATION: Remote in Cambridge, MA or Seattle, WA – eligible residents of the following states will be considered: IN, NH, NM, NY, NC, PA, SC, SD, or TX.

SALARY RANGE: $110,000 to $137,350. The midpoint of the range is $121,873. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

The Clinical Trial Manager oversees the execution activities associated with clinical trial site set-up, management, and closure for one or more clinical trials and is responsible for the successful completion of study activities at assigned clinical trial sites.

KEY RESPONSIBILITIES

• Actively participate in all aspects of clinical trial operations, including the coordination, writing, review and/or finalization of clinical trial protocols, consent forms, case report forms, study plans, safety reviews and other essential regulatory documents.
• Drive start-up, conduct, and close-out activities at assigned clinical trial sites.
• Assist with the selection and training of qualified investigators and clinical trial sites.
• Review monitoring reports and follow-up letters.
• Conduct risk assessments, mitigation strategies and contingency planning for assigned clinical trial sites.
• Oversee budgets and invoicing for assigned clinical trial sites.
• Develop and manage timeline and metrics for assigned clinical trial sites.
• Provide feedback to clinical project management team members regarding vendor related activities impacting the clinical trial sites.
• Communicate with internal teams to proactively recognize challenges at assigned clinical trial sites and collaborate on strategies to mitigate/resolve.
• Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice at assigned clinical trial sites.
• Supervisory Responsibilities: None
• Some travel would be required for educational seminars, study oversight and site engagement visits.
• Ability to travel approximately 15%.

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 leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. 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: Everyone is a shareholder at Aurion Biotech. We offer competitive equity grants, salaries, and bonuses.
• 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.

Requirements

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 health profession, science and/or engineering field.
• A minimum of 5 years of experience in a medical device, biotechnology, pharmaceutical company, CRO or clinical trial site.
• Some monitoring experience is preferred.
• Previous study coordinating or management experience preferred.

REQUIRED SKILLS AND ABILITIES

• Excellent written and oral communication skills.
• Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
• Excellent organizational skills and attention to detail.
• Ability to apply knowledge of GCP and applicable regulations and guidances appropriately