Clinical Manager, Post-Market Studies and Registries

Clinical Manager For Post-Market Studies And RegistriesSetPoint Medical's Clinical Manager for Post-Market Studies and Registries is responsible for leading the design, execution, and ongoing management of the company's post-approval studies, clinical registries, and real-world evidence (RWE) initiatives. This role is instrumental in generating clinical evidence that answers real-world practice questions beyond the scope of premarket trials, including long-term effectiveness, comparative performance, and patient-reported outcomes, while continuously monitoring device safety and performance as products are used in everyday clinical practice.This is a highly cross-functional role. The Clinical Manager works closely with Sales and Marketing to understand the clinical questions surfacing from the field and to translate study and registry findings into evidence that supports value communication, publications, and market development, while maintaining appropriate firewalls between evidence generation and promotional activity. The role also partners with Medical Affairs, Regulatory Affairs, and Health Economics and Outcomes Research (HEOR) to ensure evidence-generation plans align with regulatory obligations (e.g., post-market surveillance) and market access needs. In a fast-paced start-up environment, this role will need effective communication skills, the ability to excel under pressure, the ability to follow a task from start to finish, and excellent cross-functional team collaboration.RequirementsEvidence Strategy and Study Design•Design and manage post-market studies and product/disease-state registries that generate real-world evidence on long-term safety, effectiveness, and performance.•Translate open clinical practice questions from physicians, field feedback, and market trends into structured evidence-generation plans and study protocols.•Contribute to the annual clinical evidence strategy and post-market surveillance plan, identifying new registry and study opportunities as the portfolio of product indications grow.Study and Registry Operations•Oversee day-to-day registry and study operations, including site selection and activation, data collection instruments, enrollment tracking, and data quality monitoring.•Manage relationships with external registry partners, academic collaborators, CROs, and key opinion leaders (KOLs) involved in post-market data collection and publication.•Ensure all post-market studies and registries are conducted in compliance with GCP, applicable regulations and standards, and company SOPs, including informed consent and IRB/ethics committee requirements where applicable.•Track and report study and registry enrollment, data quality, and evidence-generation milestones to Clinical Affairs and cross-functional leadership.Safety Monitoring and Regulatory Alignment•Continuously monitor real-world safety and effectiveness signals emerging from registries and post-market studies; escalate potential safety trends to Clinical Safety and Medical Affairs per company procedures.•Collaborate with Regulatory Affairs to ensure post-market studies satisfy post-market surveillance obligations, as well as applicable FDA post-approval and post-market requirements.Cross-Functional and Commercial Partnership•Partner with Sales and Marketing to identify the evidence gaps that matter most to customers and the field, keeping study and registry designs grounded in real-world clinical practice.•Support Marketing and Medical Affairs in translating study and registry findings into scientific communications, congress presentations, publications, and sales-enablement materials, while maintaining appropriate separation between clinical evidence and promotional claims.•Work with HEOR and Market Access to align registry data collection with outcomes and value-evidence needs (e.g., payer-relevant endpoints, health economic data).Publications and Scientific Communication•Lead publication planning for post-market studies and registries: identify publication opportunities, develop abstracts and manuscripts with investigators, Medical Affairs, and/or medical writers, and manage submission timelines for target journals and scientific congresses.•Coordinate internal review and approval of abstracts, posters, and manuscripts prior to submission, ensuring scientific accuracy, data integrity, and compliance with company publication policy and authorship guidelines (e.g., ICMJE).•Maintain a rolling publication calendar across all post-market studies and registries, covering abstract deadlines, meeting/congress presentations, and manuscript milestones.Minimum Qualifications•Bachelor's degree in life sciences, nursing, or a related clinical or health field; Master's degree preferred.•6-8+ years of clinical research experience, including direct experience with post-market studies, registries, or real-world evidence programs.•Working knowledge of post-market surveillance, as well as applicable FDA post-market expectations (e.g., post-approval studies).•Demonstrated ability to design pragmatic, real-world study or registry protocols that answer clinically meaningful questions.•Strong cross-functional collaboration skills, with proven experience working alongside Sales, Marketing, or Medical Affairs teams while maintaining compliant boundaries between evidence generation and promotion.•Experience supporting scientific publications, including drafting or coordinating abstracts, posters, and manuscripts derived from clinical study or registry data.•Excellent written and verbal communication skills; comfortable presenting evidence and study updates.•Proficiency with clinical data capture and registry platforms (e.g., EDC systems) and standard analytics and reporting tools.Skills & Abilities•Clinical background (e.g., nursing, physician assistant, or allied health).•Track record of peer-reviewed publications or accepted abstracts at major scientific or medical congresses relevant to the therapeutic area.•Familiarity with HEOR concepts and payer evidence needs.•Professional certification such as CCRP, CCRA, or RAC.•Prior experience managing external KOL or registry partnerships.Physical Requirements•Ability to perform routine physical tasks, including lifting to 20 pounds.•Comfortable working in a sitting position and performing repetitive tasks.Work Location and Travel•Requires regular onsite presence at company headquarters in Valencia, CA, with remote workdays permitted in accordance with company policy.•Must reside in the Minneapolis/St. Paul area to be eligible for remote work.•Travel: Minimal travel, based on interest and business needs.Company DescriptionSetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases.