Clinical Affairs Manager

Job Description Summary

The Clinical Affairs Manager is responsible for planning and executing the clinical strategy and activities to develop Caption Health's lung AI products and obtain clearance by the FDA.

** No Sponsorship for this role now or in the future **

Job Description

**** No Sponsorship for this role now or in the future ****

In this role you will:

• Assist in development and execute clinical strategy for new AI products for lung indications including the development of clinical evaluation plans in compliance with FDA guidelines, GCP requirements, and recent FDA submissions for similar products.

• Function as a Subject Matter Expert where appropriate.

• Lead clinical activities as above in alignment with business goals and objectives. Assist with establishing, managing, and achieving project milestones with internal staff, other departments, and all study investigators and research coordinators.

• Oversee the progress of projects and ensure adherence to intended timelines including enrollment, clinical supplies, and data management/delivery. Identify issues that may impact the overall project plan and initiate contingency plans as appropriate.

• Establish and maintain relationships with outside institutions and KOLs required to conduct the appropriate studies including recruiting investigational sites and negotiating and maintaining budgets and contracts.

• Assist with generation of final reports appropriate to support regulatory filings.

• Perform other duties as assigned.

Basic Qualifications:

• Knowledge of regulations and industry standards affecting clinical studies of AI products.

• Technical expert in the various aspects of the clinical evaluation process.

• History of contribution to the success of planning and executing clinical strategies in support of product clearance.

• Experience in all aspects of clinical trial design and execution.

• Strong interpersonal skills.

• Excellent organizational skills and attention to detail.

• Ability to manage multiple priorities.

• Proficient with Microsoft 365 or similar software.

Eligibility Requirements:

• Must be willing to travel as required.

• Bachelor's or Master's degree required from an accredited university or college in science, engineering, clinical, or equivalent (medical/science background highly desired).

• A minimum of 3-5 years of clinical research experience required with 1-2 years experience leading clinical projects.

Desired Characteristics:

• Experience in AI and lung ultrasound a plus.

**** No Sponsorship for this role now or in the future ****

For U.S. based positions only, the pay range for this position is $112,640.00-$168,960.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (~~~) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

Application Deadline: July 22, 2024