The Clinical Project Manager is a seasoned professional with wide-ranging experience and a thorough understanding of GCP and ICH principles. Working under the direction of Senior Manager of Clinical Affairs, a successful candidate identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the Clinical Project Manager will establish strong, positive relationships with both internal and external partners. A successful candidate contributes to the determination or development of methods and procedures at the project and company level. The Clinical Project Manager must be self-motivated, independent and able to work efficiently in a small team environment. A successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities. Acting as the primary point of contact for investigator sites being responsible for ensuring the clinical trial is conducted according to CFR, ICH and GCP guidelines is a must.

Essential Functions

• Assist in the design, planning and implementation of clinical research projects, including drafting project plans and timelines as needed
• Manage the development of protocols, Investigator Brochures, monitoring plans, case report forms, informed consents, study manuals and study budgets
• Negotiate and finalize site contracts and budgets, manage and calculate site payments
• Perform site visits including site qualification, initiation, monitoring and close-out visits
• Work with CRO to train and supervise regional monitors and review monitoring reports
• Ensure sites comply with study protocol (to ensure accurate and complete data collection) and federal regulations
• Liaise with study site personnel to ensure timely and correct entry of data into eCRF,including the timely resolution of data queries
• Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e.., study-site webinars, newsletters or other potential creative solutions)
• Maintain frequent CRO and site contact; prepare, track, and manage required study documentation and supplies
• Oversee and track project progress at assigned sites (subject status, safety/adverse events, CRF completion, payments, clinical sample management, regulatory documents)
• Determine and oversee site investigational product requirements and accountability and other supply requirements
• Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities
• Plan and coordinate Investigator Meetings
• Assist in preparing interim study analyses, annual reports, and clinical study reports
• Manage external vendors, develop study specifications, and finalize vendor contracts; vendors may include and are not limited to Contract Research Organizations (CROs), central laboratories, interactive voice response service for randomization (IVRS)
• Participate in internal and external audits
• Represent SetPoint Medical in a professional manner; establish and maintain good relationships with investigators, study site personnel, and collaborators

Education, Experience and Skills Requirements

• BA/BS degree in science, pre-medicine, nursing, bioengineering, or a related academic field
• At least 8 years of industry experience in planning and managing clinical trials for a pharmaceutical or Class III medical device company
• Demonstrated ability to supervise a clinical trial from initiation to close in accordance with regulations and with company policies and procedures
• Thorough knowledge of GCP, ICH and FDA regulations
• Strong organizational skills, detailed oriented, and able to multi-task and work effectively in a fast-paced environment
• Self-motivated, assertive and able to function independently and as part of a team
• Strong written and verbal communication; strong interpersonal skills

Other Requirements

• Position will require travel within the US, up to 30%.

Relocation

Not available

Location

Company Headquarters in Valencia, CA

Company Description

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

The Senior Regulatory Affairs Specialist will be responsible for developing regulatory strategy, preparing regulatory submissions and obtaining approval to introduce SetPoint therapies to markets worldwide.

Job Responsibilities

• Provide regulatory support for new products/therapies
• Develop regulatory strategies that align with business goals
• Lead preparation of regulatory submissions for new products and product changes as required to ensure timely approvals and market release
• Negotiate submission issues with agency personnel
• Lead cross-functional team efforts to resolve potential regulatory issues and questions from regulatory agencies
• Establish and maintain good relationships with agency personnel
• Maintain proficiency in worldwide regulatory requirements
• Monitor and interpret changes to regulatory requirements
• Assess impact to projects/processes and communicate this information to departments within the company that may be affected by these changes
• Create, review and revise SOPs, and other company and departmental procedures to ensure compliance
• Represent Regulatory Affairs on Material Review Board, CAPA Review Committee and Change Control Board
• Participate in the planning, conduct, and reporting for external audits as requested
• Take on miscellaneous projects as assigned

Minimum Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related medical/scientific field
• Minimum of 3-4 years of regulatory experience in healthcare industry (i.e. medical device, pharma/drugs, biologics, biotech)
• Experience in regulatory submissions (i.e. writing/developing/preparing/creating submissions for medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III devices)

Preferred Qualifications

• Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files, 30-day Notices, and Real-Time Reviews
• Regulatory Affairs Certification (RAC)
• Experience with regulatory support of clinical trials
• Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
• Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements
• Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards
• Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations. Ability to compile data and summarize results
• Organized, efficient, process-oriented; high attention to detail
• Effective interpersonal/communication skills
• Works well under pressure in a dynamic timeline-driven environment
• Ability to effectively manage multiple projects and priorities

Relocation

Not available

Location

Company Headquarters in Valencia, CA

Company Description

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

SetPoint Medical is seeking an experienced, high caliber Senior Field Clinical Engineer (Sr. FCE) to support the pivotal clinical trial studying its proprietary platform in patients with Rheumatoid Arthritis. Sr. FCE will be responsible for supporting the surgical implantation and therapy programming procedures, by providing clinical consultation and training on the use of the system and its appropriate application. The Sr. FCE may be required to manage one or more FCEs and may lead clinical training initiatives. Sr. FCE will also train clinical staff on study protocols and devices, support patient recruitment and follow-up, and will act as the liaison between the company and clinical study sites to ensure the quality of patient care, data integrity and regulatory compliance are in accordance with clinical protocol requirements.

Job Responsibilities

• Represent the company at clinical study sites by providing consultative support to physician investigators as well as clinical study staff.
• Participate in development of clinical study materials, such as protocol design, source documentation, work instructions, patient recruitment materials and product training.
• Assist with site selection process including field technical assessments. Develop relationships with hospital and practice administrative staff and execute clinical study contracts where appropriate. Support site qualification, initiation and data monitoring activities.
• Demonstrate outstanding product knowledge and train physician investigators and their support team on SetPoint system.
• Attend surgical implantation and clinical follow-up visits in order to ensure clinical study execution in accordance to the protocol requirements. Provide technical and clinical support by acting as a resource to ensure optimal system implant, programming, performance, and outcomes.
• Lead patient recruitment, device management, device programming, device troubleshooting, regulatory compliance, complaint reporting and data management at assigned clinical study sites.
• Implement patient coordination plan by appropriately organizing resources to ensure a smooth transfer of patients, and their corresponding medical information, from the clinical practice to the surgical facility and back to the clinical practice.
• Provide feedback from the site, cases, physicians, patients and staff to assist in developing future training materials and presentations for new surgeons and site personnel. Provide customer feedback on product performance and possible improvements or new product ideas to R&D, clinical and quality teams
• Complete administrative and training requirements on time and accurately.
• Maintain company standards involving ethical and moral character, and always represents the company with the highest professional standards.

Minimum Qualifications

• Bachelor's or Master’s degree in Biomedical Engineering or an equivalent scientific discipline, with a minimum of 7 years of directly related experience with active implantable devices and therapy programming
• Proven experience developing and maintaining strong relationships with physicians, patients, and site staff
• Understanding of engineering principles, human physiology, physician and hospital practices, and operating room etiquette
• Prior experience providing didactic or in vivo surgical training
• Strong clinical study and technical aptitude with strong understanding of Good Clinical Practice
• Ability to fulfill and maintain background and health requirements necessary to gain access to clinical study centers, including surgical operating room locations
• Motivated self-starter with ability to work independently as well as collaboratively in a diverse cross-functional team environment
• Excellent verbal and written communication, presentation and training skills
• Ability to think quickly on your feet and respond to needs as they arise
• Ability to travel within US and internationally (up to 90%)

Preferred Qualifications

• Extensive experience with neurological active implantable devices
• Experience working with neurosurgeons is strongly preferred
• Experience conducting pivotal clinical trials for start-up medical device companies
• Experience working cross-functionally, especially with reliability engineers, quality engineers, and failure analysts, and demonstrated ability to thrive in a fast-paced R&D environment.

Relocation

Not required

Location

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

Company Description

SetPoint Medical is a privately-held medical technology company pioneering bioelectronic medicine therapies as a safe, cost-effective alternative to drugs and biologics for patients with debilitating autoimmune diseases such as Rheumatoid Arthritis, Crohn’s Disease and Multiple Sclerosis.