Sr. Clinical Affairs Manager

Sr. Clinical Affairs Manager

• United States
• Clinical
• Full Time
• Remote

APPLY FOR THIS JOB

RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. RapidAI is empowering physicians to make faster decisions for better patient outcomes, leading the next evolution of clinical decision-making and patient workflow. Based on intelligence gained from over 10 million scans in more than 2,000 hospitals in over 60 countries, the Rapid® platform transforms care coordination, offering care teams a level of patient visibility never before possible. RapidAI – where AI meets patient care.

We are seeking a skilled Senior Clinical Affairs Manager to spearhead and optimize our clinical research initiatives. You will orchestrate data coordination, study design, and stakeholder engagement across various business functions, ensuring regulatory compliance and accelerating product development. With a proactive mindset and deep expertise in clinical processes, you will play a pivotal role in driving clinical evidence for regulatory filings and guiding our products through successful market clearance.

What you will do:

• Coordinate data requests from AML/Regulatory teams for product development and testing
• QC data and distribute to proper company stakeholders.
• Design and coordinate studies to stratify existing products and proactively drive clinical solutions to solidify clinical evidence for regulatory filings.
• Operate independently across business functions in support of VP Clinical, data management, engineering, and regulatory teams.
• Manage/coordinate marketing studies across internal functions including Clinical, Research and Product Development.
• Development of study/trial protocols providing clinical input to IDE filings (with Regulatory) if necessary, and work with partners institutions and physicians to drive effective timelines.
• Monitor studies in accordance with regulatory requirements, Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and the Good Manufacturing Practices (GMPs).
• Advanced understanding of imaging modalities (MR, CT, etc.) to help align clinical and engineering validation requirements to accelerate regulatory clearances worldwide.
• Statistical analysis of development data; knowledge of diagnostic analysis techniques.
• Working with the product development team ensure source data is available prior to test timelines including the actors necessary to perform the studies.
• Working knowledge of FDA and EU regulations and guidances for clinical activities and post market analysis.
• Proactive approach to preparation and preventative action for future indications.
• Support the Post Market Clinical Plan (PMCP) and Post Market Clinical Follow-up (PMCF) annually.
• This position does not have direct reports.
• Perform any other related activities assigned by reporting manager.

What you bring:

• BS/BA or higher in relevant scientific discipline or equivalent
• 5+ years’ experience in clinical study/clinical research and market studies working in a medical device related environment and product line.
• Experience procuring, curating and managing validation data for FDA submissions.
• Experience with imaging-based vascular clinical studies preferred.
• Strong writing skills. (i.e., reports, protocols, communication)
• Pro-active process driving
• Pro-active problem solving
• Able to communicate effectively across the organization and with research collaborators worldwide.

What we offer you:

• RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
• Medical Benefits – We offer a range of policies through TriNet 
• Life Insurance/AD&D is 1X times your annual salary
• We pay 100% for Short and Long Term Disability.
• Healthcare and Dependent care flexible spending accounts are available
• A 401k plan is offered through Empower
• RapidAI provides $100 a month for internet/cell/phone services.

Time Off:

• We have 10 company paid holidays!
• RapidAI has a flexible vacation policy.  We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.

Other Cool Benefits:

• Equity – Stock Options
• Incentive Compensation
• And most importantly – You are joining an awesome team!

Compensation – The salary range target for the role described in this job description is $95,000 to $120,000. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.

RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Please review our CPRA policies here.

For more information on the information we collect about our applicants and how we use it, see our CPRA Privacy Notice here.

Please click here to apply.