Clinical Manager, Post-Market Studies and Registries

SetPoint Medical is hiring a Clinical Manager to lead the design, execution, and management of post-approval studies, clinical registries, and real-world evidence initiatives. The role monitors real-world safety and effectiveness and partners across Clinical Affairs, Medical Affairs, Regulatory Affairs, Sales, Marketing, and HEOR to support evidence generation, publications, and market access needs.

Responsibilities:

• 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
• 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
• 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
• 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)
• 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

Requirements:

• Bachelor's degree in life sciences, nursing, or a related clinical or health field
• 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
• Clinical background (e.g., nursing, physician assistant, or allied health)
• Prior experience managing external KOL or registry partnerships
• Master's degree
• 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