Reports to:     SVP Clinical Operations & Biometrics           Location:        NY or NC

Job Summary

The Clinical Project Manager is responsible for the routine cross-functional operations of assigned studies.  The Clinical Project Manager acts as the team leader, ensuring that assigned studies are delivered successfully, on-time, within budget, according to the expectations and with the highest level of quality possible.

Responsibilities

• Responsible for the overall coordination and management of clinical trials from start-up through close-out activities.
• Serve as the primary liaison with the project team for assigned studies.
• Oversee activities with respect to regulatory document collection and Trial Master File maintenance for applicable studies and directly assist with such activities as needed.
• Negotiate site contracts and/or budgets and oversee accurate and timely distribution of investigator grants.
• Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects.
• Develop, implement and communicate project plans, monitoring plans, regulatory plans and all other applicable study materials.
• Facilitate team training in accordance with the protocol and/or project requirements, including therapeutic, protocol specific and process training.
• Direct all project staff across functional areas to facilitate study progress.
• Assist with initial investigator recruitment and evaluation by reviewing site feasibility questionnaires and investigator CVs.
• Develop study specific Standard Operating Procedures (SOPs) and other study-specific management tools as needed.
• Coordinate, plan and execute Investigator Meetings as needed.
• Oversee the supply of Investigational Product and other study materials to sites.
• Evaluate site activation and site enrollment against projections throughout the course of the study, escalating issues as required.
• Determine and implement patient retention strategies as needed.
• Assist with resolution of site and facility issues such as outstanding queries, overdue documentation, lab and study drug issues.
• Manage overall study budget, provide accurate budget forecasts, review pass-through costs and ensure project invoices and site/vendor payments are accurate, timely and in alignment with applicable agreements and Statement of Work (SOW).
• Lead internal project team meetings
• Communicate the progress of the study, potential risks and appropriate recommendations for identified risks to appropriate client and internal team members on a regular basis.
• Attend project team meetings.
• Oversee the creation and distribution of study-specific newsletters as required.
• Ensure monitoring reports are received, reviewed and signed off per specified timelines as defined in the Monitoring Plan and/or applicable SOPs.
• Ensure project documentation is complete, current, stored appropriately and audit-ready.
• Develop and maintain a close working relationship with study management team.
• Establish a strong working relationship with and act as a resource for investigative sites; troubleshoot site and patient concerns and critical project matters.
• Escalate issues and critical project matters in a timely manner to appropriate team members and senior management.
• Support study audits and respond to audit reports.
• Provide performance feedback on project team members to management.
• Collate and communicate end-of-study site performance metrics, issues and lessons learned to appropriate parties.

Qualifications / Requirements / Experience

• Bachelors degree or RN in related field
• PMP Certification a plus
• 5+ years of experience in clinical trials in medical device or life sciences technology-driven company.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• At least 3 years of Clinical Project Management experience in CRO setting
• Ability to travel as needed (investigator meetings & sites meetings)
• Experience in managing a group of CRA’s
• Work outside the normal office hours as required.  

Specific Criteria:

• Experience in establishing relationship with key opinion leaders, investigators and study personnel, especially in the respiratory field
• Exceptional negotiating skills along with financial acumen
• Strong knowledge of the device and drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
• Excellent written, oral communication and presentation skills
• Excellent interpersonal and organizational skills with demonstrated attention to detail.
• Ability to read, write and speak fluent English.
• Ability to build positive, productive client and team member relationships.
• Demonstrated management and problem-solving capabilities, strong critical thinking, and analytical skills
• Good computer skills with good working knowledge of a range of computer applications included but not limited to MS Work and Excel
• Ability to meet deadlines, multitasks, and prioritize based on project needs
• Ability to make sound decisions based on available information
• Ability to work both as part of a team and independently
• Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Reports to:     VP Engineering                                  Location:        Madison, Wisconsin Area

Job Summary

This temporary position will be responsible to perform verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.

Responsibilities

• Verification and Validation of embedded as well as application software for complex system interactions in medical devices
• Develop software verification protocols for the design and development of the system/subsystem, review requirements, develop test scenarios, review and approve protocols, perform the execution of the protocols, analyzes results, and write reports
• Responsible for verification around the various aspects of the software platform of the medical device to account for user interactions, performance, safety and functionality.
• Executing the verification activities to support the software verification for projects under new product development (NPD) and/or Life Cycle Engineering (LCE) initiatives of medical device development.
• Executing the verification activities to support tool validation.
• Fulfilling activities to comply with the project deliverables outlined in the Design and Development Plans and Design Control Procedures, as applicable.
• Tracking and document discrepancies, as applicable, during verification.
• Support and maintain Continuous Integration, Continuous Testing, Continuous Deployment infrastructure
• Critical analysis of technical situations, identifies problems, and work with the cross-functional team in resolving the problems.
• Effectively collaborates within cross-functional teams to convey problems, opportunities, solutions and results in the medical device development
• Actively engage in continuous improvement initiatives to establish a Center of Excellence (CoE) in Software Assurance function.
• Performs other duties as assigned

Qualifications / Requirements/Experience

• New grad or student with at least two years completed towards a Bachelor’s degree in Computer Engineering, Electrical Engineering, Electronics Engineering, Biomedical Engineering, or equivalent.
• Ability to understand functional/technical specifications
• Possess excellent analytical and troubleshooting skills must be self-motivated, willing to learn new concepts, technologies and products quickly
• Desire to work as a software test engineer completing verification testing on a safety-critical regulated product (i.e., med device)
• Desire to learn to use tools such as Rational Quality Manager, ReqView, JIRA, Git
• Working knowledge on OS such as Windows
• Ability to troubleshoot and make quick knowledge and experience-guided decisions
• Excellent written, communication, presentation and social skills, with meticulous attention to detail that extends beyond written and verbal communication
• Excellent people skills, ability to partner well, good team camaraderie
• Proficient with Microsoft Office tools especially MS Word, MS Excel

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Reports to:     Director, Clinical Operations                         Location:        Remote

Job Summary

Working under minimal direction, provides educational, technical and customer support for clinical issues concerned with the safe and correct implementation of Beyond Air medical devices. Engage and work closely with stakeholders (physicians, health care professionals, patients, and commercial team) involving Beyond Air products. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes.

Accountabilities

• Has a basic understanding of the competitive landscape in nitric oxide delivery devices
• Demonstrates ability to build and sustain clinical support relationships with customers and shares product expertise accordingly.
• Evaluation of new devices and review of all associated educational and support material provided to customers.
• Identifies, reports and advises of customer needs and product performance to the field-based teams / directors and/or management
• Develops, leads and/or facilitates trainings and other programs on Beyond Air products to healthcare professionals.
• Provides insight, guidance, and feedback to management on market feedback and components for future or next generation of products.
• Continuously develops clinical and technical skills and supports the commercial team strategic plans in patient care clinical trials
• Completes other tasks as necessary

Activities:

• Provide in-person or video-supported training to medical personnel in the hospital or clinic setting.
• Provides on-call support as needed on evenings and weekends post sign-off
• Operational Support
• Helps manage customer inventory needs and requests as required
• Provides education and clinical support in response to clinical field inquiries on as-needed basis. Demonstrates a thorough command of all products, related products and technical knowledge.
• Assist with Beyond Air device investigations on clinician-reported performance issues.
• Trouble Shooting
• Provides back-up support to Sales & Customer Support Representatives in the following areas:

• Internal Training
• External device training to Physicians, Nurses and Respiratory Therapists
• Clinical studies/data collection.

Requirements:

• Registered Respiratory Therapist, BSc
• Minimum 8-10 years of experience in respiratory medical device clinical support.
• Minimum 5 years clinical experience in an ICU environment.
• Experience in the Respiratory field specifically supporting Nitric Oxide products / devices highly desirable.
• Demonstrated knowledge of wide range of respiratory therapy devices and treatments
• Familiarity with respiratory therapy procedures and protocol.
• Demonstrated advanced knowledge nitric oxide delivery systems is highly preferred.
• Must have comprehensive written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to meet deadlines.
• Must have the ability to concentrate on detail and work independently.
• Must be able to work effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals; must be capable of coordinating multiple assignments simultaneously and effectively.
• Must possess comprehensive computer skills (experience with Microsoft Word, Excel, Powerpoint or equivalent required).
• Self-motivated and able to work independently, whilst maintaining inclusive approaches.
• Excellent time management skills and ability to work under pressure to deadlines.
• Must exhibit high quality, ethical and work habits.

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

AP – AR Coordinator

Reports to:     US Controller                                                 Location:        Garden City, NY

Job Summary

As a member of the Finance department, AP/AR Assistant reports to the US Controller and is responsible for supporting the tasks related to Accounts Payable and Accounts Receivable. Accounts Payable tasks include assisting with vendor bill data entry to accounting system, obtaining and matching supporting documentation, and processing bills for payments. Accounts Receivable tasks include assisting with customer billing and collections.

Responsibilities

Accounts Payable

ESSENTIAL FUNCTIONS:

Vendor records

• Assist with maintaining accurate vendor records in accounting system, following Company’s policies and procedures

Vendor bill processing

• Assist with processing vendor bills and entering data in accounting system following Company’s AP guidelines.
• Assist with verifying billing details on vendor invoices against contractual terms.
• Perform a 3-way match of PO or vendor contract, receipt, and bill.
• Determine that the invoice terms, quantities and price matches with the purchase order
• For consultants, ensure that the company has tax reporting records to compile 1099 reporting
• Assist with obtaining support and approval of vendor bills for payment.
• Assist with investigating discrepancies in vendor billing against PO or contractual terms, contacting vendors if needed and resolving discrepancies.
• Collaborate with Purchasing in the areas of receipts and billing against PO’s.
• Assist with reviewing open PO’s in the accounting system; close PO’s as necessary.
• Assist with reconciling month end vendor statement to vendor outstanding balance.

Vendor bill payment processing

• Assist with preparing payment batches for vendor bill processing.
• Assist with applying payments to vendor bills in accounting system.
• Assist with requesting Statement of Account from vendors and verifying details with internal AP records.
• Assist with responses to vendor and internal inquiries regarding open invoices and payment status.
  
  

Accounts Receivable

• Assist with monthly customer billing and issuing customer invoices.
• Submit billing to customers.
• Assist with collections and following up with customers on past due invoices.
• Assist with maintaining support for customer billing data and internal AR records.
• Assist with reconciling month end statement to customer outstanding balance.
• Assist with customer billing issues.
  
  

Additional Duties

May perform additional duties as assigned by supervisor from time to time.

Education/Experience Required

• AA, AS, or BS in Accounting or Business-related major from an accredited university is a plus
• 3 years of experience in Accounts Payable and Accounts Receivable
• Experience with General Ledger entries is a plus
  
  

Required Skills

• Excellent data entry skills.
• High attention to detail, demonstrates accuracy and thoroughness in daily work and other projects.
• Experience with Excel.
• Strong verbal, written communication, and interpersonal skills.
• Self-starter and takes ownership of his / her work product.
• Protects organization's value by keeping information confidential.
  
  

Required Competencies

• Performance Orientation – Is driven by personal performance; achieves all objectives detailed in scorecards and comfortable with quantifiable assessments.
• Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
• Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
• Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
• Confidence - Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms.
• The employee must occasionally lift and/or move up to 10 pounds.
• Transition from standing and sitting often.

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Reports to:     Head of Global Supply Chain                        Location:        Dublin, Ireland

Job Summary

The Materials Planner will work under direct supervision of the Head of Global Supply Chain to perform activities, achieving internal and external customer service goals, optimizing inventory and minimizing cost. This includes proactive risk mitigation, supply execution oversight, monitoring and reporting of results; and may include capacity planning, logistics execution and process ownership of administrative tasks to enable the efficiencies of the larger Beyond Air team.

Accountabilities

• Plan purchases for assigned products, projects, and commodities and negotiate and implement appropriate buying methods. Develop Purchase Requisition per procedural requirements and Product Specifications, issue purchase orders, confirm deliveries, and expedite deliveries as required. Request bids from suppliers as needed
• Plan and direct finished goods shipments between 3PL to final end-user and ensure timely delivery as well as inventory accuracy and serial number/lot number traceability in NetSuite.
• Maintain, monitor, and enhance the internal purchasing system to continuously meet production requirements. Use various tools like MRP to make sure appropriate inventory levels are maintained. Maintain and publish accurate tracking systems to keep all stakeholders informed of any potential disruptions in the supply chain.
• Requisitions material and establishes sequential delivery dates to departments, according to job order priorities and material availability.
• Coordinates and directs movement or transfer of materials and completed parts to meet the master production schedules.
• Establish standard cost for purchased items and maintain the standard cost files.
• Serves as backup to the Head of Supply Chain
  
  

Activities:

• Support S&OP process as required engaging with Sales Operations and Finance.
• Interact with Clinical Support Team and coordinate return shipments from end users to the appropriate facility for review and checkout.
• Working closely with Engineers and Head of Global Supply develop alliances with Beyond Air’s suppliers to manage supplier performance and develop plans to alleviate any supply chain risks.
• Actively participate in MRB as required and ensure timely disposition of rejected material from supplier and assist SE/Engineering/Mfg. Engineering/Quality on corrective action and recovery plan.

Requirements:

• A. or B.S. in Business, Supply Chain or a related field
• 3-5 years or more of work experience in purchasing, materials planning and supply chain management. Medical device experience preferred.
• Excellent communication and presentation skills
• Strong analytical, decision making and problem solving skills
• Demonstrated high level of business judgment. Ability to deal with suppliers, customers and cross-functional departments positively, responsibly, and professionally.
• Must be proficient in Microsoft Office Suite. NetSuite experience is preferred
• Knowledge of LEAN, six sigma, kaizen, and continuous improvement initiatives.
• Green Belt a plus
• Must be able to adapt to changing priorities and tasks and demonstrate flexibility in a changing business environment. Models a positive can-do attitude and is cooperative both within their function and company-wide
• Ability to prioritize tasks in a timely manner with minimal supervision
• Demonstrate a strong commitment and dedication to the organization on a consistent basis

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.