The Clinical Data Manager is responsible for supporting clinical affairs by working collaboratively to ensure data is collected, managed and reported clearly, accurately, securely and on time. The Clinical Data Manager reports to the Senior Manager of Clinical Affairs. This is a contract position.

Job Responsibilities

Include but are not limited to the following:

• Contribute to the design and validation of clinical databases, including designing and testing CRFs and logic checks.
• Confer with end users to define or implement clinical system requirements such as data transfer formats, delivery schedules, and testing protocols.
• Contribute to development of procedural documents (e.g., standard operating procedures, work instructions, and data capture guidelines). 
• Develop, maintain and implement project-specific data management plans that address areas such as data coding, reporting, transfer, database locks, and workflow processes (e.g., Data Management Plan, CRF Completion Guidelines, Medical Coding Guidelines).   
• Perform or oversee ongoing data reviews, external data reconciliations, trend analysis, and query management.  
• Query data inconsistencies, errors and omissions and track queries to resolution.
• Escalate systemic and critical data issues to ensure properly and promptly addressed.
• Ensure all activities under responsibility are properly documented (traceability of changes, data specifications) according to the internal guidance documents.
• Provide data exports, standard/ad hoc clinical data listings and metric reports to support ongoing data cleaning activities and project needs. 
• Oversee timely completion and accuracy of medical coding; lead ongoing medical coding reviews ensuring final review and approval. 
• Participate in ongoing adverse event, protocol deviation, and device deficiency reviews.
• Collaborate with and mentor study team on clinical data management activities and procedures. 
• Train staff on usage of clinical databases.
• Perform quality control audits to ensure proper, authorized usage of clinical systems and data. 
• Lead and coordinate database lock procedures, including all QC efforts.
• Work according to ICH-GCP, other international guidelines (e.g., ISO), working group recommendations (e.g., CDISC or Good Clinical Data Management Practices) as well as internal quality system.

The Manager of Clinical Affairs is responsible for supporting clinical affair’s activities such as planning, execution and reporting of company’s clinical trials. The Manager of Clinical Affairs possesses a unique combination of managerial experience and tactical/operational skillsets related to clinical systems, data management and biostatistical analysis. This position also contributes to the preparation of clinical study protocols, reports and publications. The Manager of Clinical Affairs reports to the Senior Manager of Clinical Affairs.

Job Responsibilities

Include but are not limited to the following:

• Supports development of clinical strategies and protocols for product approvals and expanded indications
• Establishes and manages Clinical Data Management (CDM) processes and standards. Ensures coordination and standardization of development and implementation of data collection procedures. 
• Directs development and management of database systems and Ensures coordination and implementation of data collection procedures 
• Support medical monitoring reports, safety reviews, and reviewing tables, listings and figures.
• Analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
• Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety.
• Provides oversight of biostatistical programming and analysis. Ensures coordination and implementation of  statistical analysis plans and analyses of study data.
• Manages clinical vendors and consultants. Creation of RFP, solicitation of bids, evaluation of services from data management to biostatistics and medical writing.
• Writes exceptionally well. Can write clinical protocols, reports, papers, has a keen eye for technical writing. Has authored or co-authored scientific and medical papers 
• Contribute to ICFs, training documents, and other clinical documents under the direction of the Senior Manager of Clinical Affairs.
• Contributes to preparation of clinical sections of regulatory submissions, justifications, responses to FDA questions
• Establishes good rapports with investigators, reinforcing importance of timely and high-quality data collection

As a member of the SetPoint Medical Operations team, the Manufacturing Engineer will be responsible ensuring and improving the manufacturing processes, and components of SetPoint’s novel medical device. The ideal candidate will have a robust understanding of medical device systems engineering, and medical device manufacturing. As specific tasks arise, the individual will need to gather relevant data, undertake independent research, formulate hypotheses, conduct experiments as needed, as well as draft reports for submission to quality and regulatory bodies. 

 The Manufacturing Engineer will play a meaningful role in the development and implementation of continuous improvement efforts within the organization.

Position Responsibilities:

• Interface with Product Development, Operations, and Quality departments to ensure technology transfer for new products is performed in accordance with regulatory and manufacturing site requirements.
• Assist in test plans, sampling plans, acceptance criteria, process validation, protocols and reports. Facilitating documentation of functional, electrical, and mechanical drawing and specifications.
• Plan, Preform, Report qualification activities (IQ, OQ, and PQ)
• Evaluate manufacturing processes by designing and conducting research activities; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with contract manufacturers by soliciting observations from operators
• Assist in development of manufacturing processes by studying product requirements, researching, designing, modifying, and testing manufacturing methods and equipment
• Provide manufacturing engineering information by answering questions and requests
• Work with contract manufactures to identify and implement process improvements
• Perform acceptance activities such as CAPAs, NCRs, QMS, process improvements, and operator training
• Create and manage documentation of functional, electrical, and mechanical specifications and drawings
• Assist with other engineering activities as required

The Vice President of Clinical Affairs possesses a unique combination of managerial, scientific, strategic, and tactical/operational skillsets. As a key member of SetPoint Medical’s leadership team, the VP of Clinical Affairs is accountable for the leadership, strategic planning, oversight, and execution of clinical programs. The VP of Clinical Affairs is responsible for designing clinical trials (from FIM to Pivotal trials; US or OUS), analyzing clinical data and providing clinical operations function (study management, timelines, budgets, study monitoring), with the immediate focus on conduct of an RCT pivotal study to support a PMA. The VP of Clinical Affairs works closely with Medical, Regulatory, Quality, and R&D teams on the execution of the pivotal study, and, in the future, the design of clinical development programs. The VP of Clinical Affairs reports to the CEO.

Executive Management

• Provide leadership, strategic insight, direction, and implementation of clinical affairs activities to support timely study enrollment and compliance with all applicable regulations
• Establish and maintain an adequate organizational structure 
• Establishes clear goals for the department that tie into the broader company objectives
• Establish clinical strategies to support device approvals (with initial focus on PMA and CE Mark) and commercialization efforts
• Has strong performance management skills to build organizational capabilities. Develops employees to stretch their skillsets, and advance in their careers; fosters exceptional teamwork across the clinical organization
• Establish and nurture collaborative relationships between clinical department and rest of company (with emphasis on R&D and Regulatory)
• Is positive, and creates a culture with a can-do attitude with strong work ethic
• Maintain a professional and credible reputation with physicians, investors, Board of Directors, professional societies, consultants, vendors, and co-workers
• Encourages continuous improvement and provides training to keep clinical departments current on best practices, medical knowledge, scientific issues and regulatory requirements

Clinical Science & Strategy

• Oversees the development of clinical strategies, study designs, clinical endpoints, protocols and analysis plans for device approvals and expanded indications
• Understands biostatistical concepts and is adept at reviewing data analyses
• Ensures appropriate safety/medical monitoring is performed
• Writes exceptionally well. Can write clinical protocols, reports, papers, has a keen eye for technical writing. Has authored or co-authored scientific and medical papers. Contributes to clinical sections of regulatory submissions, justifications, memos to file, responses to FDA questions
• Collaborates with other departments in the Company, including R&D and Regulatory to foster cohesive efforts during design and conduct of clinical studies
• Attends and presents at meetings with regulatory agencies, including FDA
• Establishes and implements plans for publication of relevant scientific data in appropriate journals
• Works closely with Chief Medical Officer in identifying and developing relationships with Key Opinion Leaders.
• Develops strong ties with clinicians and thought leaders. Develops reputation in the industry for credibility, good clinical science. Interacts and communicates effectively with medical advisors and other scientific disciplines

Clinical Operations

• Develops SOPs and guidelines, and ensure compliance with regulatory agency requirements
• Oversees clinical operations, including establishment of timelines, study budgets, site selection, patient recruitment, processing of data
• Oversees development of annual and study-specific operating budgets for the Clinical organization to meet long-term company and departmental objectives
• Oversees evaluation, selection and management of Contract Research Organizations (CRO) and consultants to supplement the department as needed
• Has conducted trials using paper CRFs and electronic data capture (EDC), IRT, IWRS, ITRS; contributes to evaluation of vendors to select appropriate platform for company’s studies
• Encourages establishment of ambitious timelines and proactive planning to complete clinical studies on time and in compliance with GCP and applicable regulations
• Travels to investigational centers. Personal travel to investigational centers is critical to study success: establishing rapport with investigators, reinforcing importance of timely, high quality data
• Travel also includes attending major meetings, meeting with clinicians on study implementation
• Authors documents including clinical study protocols, investigator’s brochures and clinical study reports, and collaborate in the preparation of manuscripts and external presentations
• Develops outsourcing strategy and oversee selection and management of clinical trials service providers and suppliers
• Accountable for Clinical Affairs department staffing,  financial planning and budget management
• Develops key talent
• Leads, collaborates with, and mentors employees in other functional areas

As a member of the SetPoint Medical management team, reporting to the President and CEO, the Director of Program Management will be responsible for the timely delivery of our revolutionary bioelectronic medicine platform. Working closely with the R&D, Regulatory, Quality and Clinical teams while managing key suppliers, they will be expected to:

• Define the structure, process and procedures to control project execution
• Generate a set of metrics to indicate the health and progress of the project
• Ensure alignment between key stakeholders in order to support a higher level vision, goals and objectives
• Develop the plan that brings together the information on key deliverables, resources and timelines
• Lead regularly scheduled reviews in order to assess progress against the plan and to ensure accountability
• Identify corrective actions to address issues and risks
• Track and report on project variables including progress, cost, effort and risk
• Manage the change control process in order to control project scope
• Compile and manage the project design history file
• Coordinate with external suppliers and developers to guarantee a smooth transition to manufacturing
• Lead, collaborate with, and mentor other employees

The SetPoint Medical Operations team is seeking a motivated, hardworking, enthusiastic, and experienced manufacturing engineer to lead failure investigations efforts utilizing a cross-functional team to process and implement successful corrective actions. The ideal candidate will have a robust understanding of medical device systems engineering, and medical device manufacturing. This individual will be well versed in the root cause analysis techniques, manufacturing process controls, and able to communicate throughout the organization effectively. As specific tasks arise, the individual will need to gather relevant data, undertake independent research, formulate hypotheses, conduct experiments as needed, as well as draft reports for submission to quality and regulatory bodies. This individual will need to strike a balance between working on their own and leveraging the assistance of others to reach well-grounded failure investigations conclusions.

The Sr. Manufacturing Engineer will play a meaningful role in the development and implementation of continuous improvement efforts within the organization.

Position Responsibilities:

• Lead Failure Investigation Team to ensure adherence to SetPoint procedures
• Take ownership to completion of failure investigations for field issues, returned products, and manufacturing nonconformances
• Collaborate with Engineers, Suppliers, Clinical Specialists, Field Service Engineers Product Development, and Quality personnel to facilitate a deep understanding of device functionality and failures and to perform in depth root cause analysis
• Work with team to help analyze/resolve product quality problems and solve complex manufacturing problems, applying knowledge of production methods and quality improvements techniques improving existing manufacturing processes
• Acquire, analyze, and interpret information from data logs and various applications as well as perform physical (hands-on) deconstruction of devices as part of root cause analysis
• Ensure compliance to SetPoint KPIs for timely closure of failure investigation and nonconformance activities
• Provide frequent verbal and written updates of work-in-progress for various meetings
• For each investigation, document methods and findings, drive to completion, and provide recommendations to the team
• Write formal reports, resulting in clear and accurate messaging about findings for a broad audience
• Advise management for trend and failure investigation process improvement
• Assist with other engineering activities as required

The SetPoint Medical Quality Assurance team is seeking a Failure Analysis Quality Engineer who will collaboratively partner with Product Development and Operations in investigating and determining the root cause of failures or device issues. This is an individual contributor role for an inquisitive and driven team-player who will become intimately familiar with our medical devices and report out on findings to assist in the development of process and product improvements. The Failure Analysis Quality Engineer plays a meaningful role in the development and implementation of continuous improvement efforts within the organization.  

Position Responsibilities:

• Provide Quality Assurance oversight of the Failure Investigation process from root cause analysis through final report
• Collaborate with Product Development, Suppliers, Field Clinical Engineers, Clinical personnel, and Manufacturing personnel to facilitate a deep understanding of device functionality and failures and to perform in depth root cause analysis
• Comprehend and provide feedback on analysis and interpretation of information from data logs and various applications
• Collaborate in the design and execution of experiments and test methods to test theories to refine failure modes and determine root cause
• Assist with physical (hands-on) deconstruction of devices as part of root cause analysis
• Utilize failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications and other test equipment and fixtures in support of failure analysis
• Critically and collaboratively review failure investigation reports to ensure clear and accurate messaging about analysis findings for a broad audience
• Provide relevant content to organizational team members ensuring that mandated reporting requirements are met
• Provide status updates of work-in-progress for various meetings
• Propose enhanced investigation methodologies and collaborate in the development and validation of new test fixtures to expedite future failure investigations 
• Ensure that analysis report findings are transitioned to the appropriate QMS module for implementation (e.g., Change Control or CAPA)
• Assist with troubleshooting of design issues, as they arise, for new and existing products
• Assist with exploring design alternatives for new system components

The SetPoint Medical Product Development team is seeking a Failure Analysis Engineer who will be responsible for the hands-on technical analysis of sophisticated devices, components, hardware, and software to determine the root cause of failures or device issues. This is an individual contributor role for an inquisitive and driven team-player who will become intimately familiar with our medical devices and report out on findings to assist in the development of process and product improvements. The Failure Analysis Engineer plays a meaningful role in the development and implementation of continuous improvement efforts within the organization.

Position Responsibilities:

• Collaborate with Engineers, Suppliers, Clinical Specialists, Field Service Engineers and Manufacturing personnel to facilitate a deep understanding of device functionality and failures and to perform in depth root cause analysis
• Design and execute experiments and test methods to test theories to refine failure modes and determine root cause
• Acquire, analyze, and interpret information from data logs and various applications as well as perform physical (hands-on) deconstruction of devices as part of root cause analysis
• Utilize failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications and other test equipment and fixtures in support of failure analysis
• Write formal analysis reports, resulting in clear and accurate messaging about analysis findings for a broad audience
• Provide frequent verbal and written updates of work-in-progress for various meetings
• Enhance investigation methodologies and develop and validate new test fixtures to expedite future failure investigations 
• Assist with troubleshooting of design issues, as they arise, for new and existing products
• Take ownership of assigned failure investigations for field issues or for manufacturing nonconformances
• Assist with exploring design alternatives for new system components

SetPoint Medical is seeking an experienced, high caliber Quality Specialist to own the Device History Record (DHR) of manufactured product and to release finished devices for use.

Job Responsibilities:

• Assists in approving incoming materials by review of any associated DHR documentation 
• Reviews and  maintains DHR documentation for all manufactured product
• Reconciles discrepancies found in DHR documentation
• Provides details on nonconformance's (NCs) found for Quality Review Board (QRB) review and disposition
• Ensures that nonconforming product is kept segregated to prevent unintended use
• Ensures that only product which has met all requirements is approved for distribution
• Provides details to QRB on deviations or nonconformance's documented in the DHR for material intended for use in design verification and validation testing or process validations
• Verifies all documentation complies with company and regulatory agency standards
• Assists in the implementation of continuous improvement processes (NC, CAPA, complaint handling)

The Senior Clinical Research Associate (Sr CRA) independently manages and monitors investigational sites and has a thorough understanding of FDA, GCP, and ICH principles. This position oversees study execution from start-up to close-out at assigned study sites, including training, monitoring, and reporting in compliance with study protocols, IRB requirements, applicable FDA regulations, and company procedures.  

The Sr CRA may act as a CRA team lead and shall be self-motivated, independent and able to work efficiently in a team environment. The Sr CRA mentors junior CRAs and participates in development of study protocol and materials. The Sr CRA will report to the Sr Manager, Clinical Operations.

Essential Functions

Include but are not limited to the following:

• Conduct site qualification, initiation, monitoring and close-out visits, submit timely reports, and assist with site selection
• Serves as the main contact for assigned study sites
• Ensure adherence to study protocols, company’s SOPs, and compliance with GCP guidelines and FDA regulations and IRB requirements
• Provide clinical support in the areas of implant procedure, basic troubleshooting, programming, and complaint reporting for the SetPoint System  
• Review source documentation, case report forms and data reports for accuracy, completeness, and timely submission
• Manage investigational product accountability 
• Communicate and work with site investigators and research staff to ensure proper reporting of adverse events and protocol deviations and escalate critical compliance issues to manager promptly
• Collect and transfer required site documents to the trial master file 
• Provide site updates at study meetings 
• Participate in the development of study documents (protocols, monitoring plans, case report forms, informed consent forms, study manuals) and EDC user acceptance testing
• Mentor and train CRAs in accordance with company procedures and ensure consistency with study practices, training, proctoring across CRA team members and clinical sites
• Review monitoring reports, trend compliance issues, create solutions and escalate to manager, as required
• May facilitate review meetings for study updates, adverse events, and protocol deviations
• Assist with routine quality audits to ensure that clinical sites maintain necessary study documentation and adhere to protocol requirement
• Attend relevant scientific meetings as directed

Location

This is a field position, requiring occasional visits to company headquarters in Valencia, CA 

The position may require travel 50-70% of the time, with periods of more frequent travel (up to 85%).

SetPoint Medical is seeking an experienced quality engineer to work collaboratively in a cross-functional environment to ensure the delivery of high-quality development projects within approved program schedules. The Senior Quality Engineer will be responsible for the generation and review of all design control and risk management activities.

All candidates will be asked to describe in detail their individual as well as team contributions towards development and testing activities within a Class II/III medical device environment.

Job Responsibilities

• Provide functional input during development project planning to accurately assess resource and scheduling considerations
• Partner with Product Development and other cross-functional team members to define design input (i.e. Customer, System, Hardware, Software Requirements)
• Review and approve design input and design output documentation
• Partner with Product Development, other cross-functional team members and consultants/external test houses to define design verification and validation testing
• Assist in the execution of dry runs and in oversight of official V&V testing
• Review and approve verification and validation test plans and test reports
• Represent as lead quality assurance team member in design review and phase review meetings
• Drive project/system level risk management deliverables (i.e. plans, Device Hazard Analyses, reports, and Risk Management)
• Review and approve other cross-functionally developed risk management deliverables(i.e. uFMEA, pFMEA)
• Review, assess, and approve all proposed changes (i.e. Engineering Change Orders, Deviations, etc.) to ensure proper level of testing supports implementation
• Verify development project documentation is in compliance with Company procedures
• Current working knowledge of 21 CFR Part 820 (QSR), ISO 13485, ISO 14971, and other standards as required
• Other projects as assigned

SetPoint Medical is seeking an experienced quality engineer to work collaboratively in a cross-functional environment to ensure SetPoint Medical’s suppliers establish and maintain the high level of quality to be a Class III medical device supplier. The Senior Quality Engineer will be responsible for the initial evaluation, classification and ongoing monitoring of SetPoint suppliers.

All candidates will be asked to describe in detail their individual as well as team contributions towards supplier management activities within a Class II/III medical device environment.

Job Responsibilities

• Maintain the Supplier Management infrastructure; proposing and implementing improvements, as required
• Collaborate with cross functional groups in selection of new suppliers
• Perform thorough supplier audits of processes and QMS driving improvements, where necessary
• Collaborate with Product Development and Operations in production supplier development by evaluating and developing supplier processes through process and/or tooling validations, conducting supplier review meetings, and trainings as needed
• Drive corrective actions/supplier corrective action requests (SCAR) within the supplier management process
• Maintain all supplier quality records, including performance metrics and reports
• Current working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and other standards as required
• Other projects as assigned