Manager of Clinical Operations

About Visby

Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.

About the Role

The Clinical Operations Manager leads a team of clinical research associates (CRAs) and clinical research assistants to effectively support Visby’s clinical studies. The manager is responsible for all aspects of clinical studies operations including development and maintenance of procedures that define the operational aspects conducting Visby’s clinical trials. The ideal candidate has extensive experience in conducting clinical studies for in vitro diagnostic devices and a passion for mentoring team members and developing efficient and compliant processes. This role will report to the SVP of Quality, Regulatory and Clinical Affairs.

How You’ll Make An Impact

• Define efficient and compliant procedures for the conduct of Visby’s clinical studies, including development and implementation of standard operating procedures (SOPs) and clinical department operating procedures (DOPs).
• Management and development of clinical research associates (CRAs) and clinical research assistants.
• Ensure the conduct of Visby’s clinical studies is in compliance with the currently approved protocol/amendment(s), with current GCP guidelines and applicable regulatory requirements. 
• Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
• Support the clinical scientists in supporting study goals and objectives.
• Partner with cross-functional teams to ensure timely achievement of clinical study objectives. 
• Management of study material inventory and logistics support for Visby’s clinical studies.
• Oversee inhouse study collections and assign duties to clinical research assistants.
• Management of Visby’s biorepository and tracking software to ensure all samples are tracked, appropriately stored and easily accessible.
• Perform other duties as assigned to ensure successful management and completion of clinical studies. 

On Your First Day We’d Like You to Have

• Bachelor’s Degree, preferably in a life science or health science discipline. 
• Minimum 5 years of related experience, preferably including clinical research and clinical operations experience.
• Experience working in IVD clinical studies highly preferred
• Strong attention to detail, self-motivation and good organizational skills.  
• Scientific/clinical knowledge to be able to understand the nature of the laboratory assays being studied. 
• High levels of integrity, intellectual honesty and maturity.
• Computer software skills (e.g., MS Word, Excel, PowerPoint and Google Products experience).
• Proficient with FDA, ICH, GCP and IATA requirements.

Physical Demands

• Must be able to travel up to 20%
• Must be able to lift a minimum of 10 lbs.

Salary Range:

• $133,760 - $167,200 (Minimum to maximum salary range for candidates based in San Jose, CA)
• Compensation for the role is based on geographical location. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly.
• Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.

 

 

More about our benefits

Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option.  We also offer a 401k match, flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.

Additional information

We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.

Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.