Clinical Research

• Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies
• Performs a variety of complex activities to appropriately compile, document and analyze clinical research data
• Coordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol
• Protect the rights and the well-being of subjects enrolled in studies
• Ensures thorough, individualized, protocol-based study subject education on all study process requirements
• Regularly evaluates the study subjects’ condition and communicates/documents concerns to PI
• Accurately documents study subject activities as outlined by the protocol

Clinical Research Coordinator II

• Serve as the Clinical Research representative on New Product Development (NPD) core teams, acting as the primary clinical voice throughout the product lifecycle—from concept through post-market evaluation
• Develop and lead clinical evidence strategies aligned to regulatory, medical, and commercial objectives, including identification of evidence gaps necessary to support safety, performance, and claims
• Critically evaluate and synthesize clinical literature and competitive evidence landscapes to inform product development decisions, clinical positioning, and differentiation strategy
• Lead and influence clinical study design, including protocol development, endpoint selection, and overall evidence generation approach to support intended use and global market needs
• Provide clinical oversight, review, and approval of product claims to ensure alignment with scientific evidence, regulatory requirements, and reimbursement strategies
• Partner cross-functionally (R&D, Regulatory, Marketing, Medical Affairs, Quality) to integrate clinical insights into product requirements, risk management, and benefit-risk assessments
• Drive development of key clinical deliverables, including Clinical Evaluation Plans/Reports, Clinical Study Reports, and other documentation supporting regulatory submissions and product commercialization
• Synthesize clinical data to support regulatory approval, evidence dissemination, and lifecycle management activities
• Identify and proactively manage clinical and patient-related risks early in development, contributing to mitigation strategies and overall product safety profile
• Influence Voice of Customer (VoC) translation and ensure clinical insights are reflected in product design, usability, and intended use

Principal Clinical Research Specialist

• Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager
• Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy
• Compile and maintain project-specific status reports within the clinical trial management system
• Interact with the internal project team, Sponsor, study sites, and third-party vendors
• Provide oversight and quality control of our internal regulatory filing system
• Provide oversight and management of study supplies
• Create and maintain project timelines
• Coordinate project meetings and produce quality minutes

Associate Clinical Trial Manager – Cardio, Renal, GI, Metabolic

• Working cross-functionally to conduct gap analyses in clinical evidence and recommending strategies in line with business goals
• Providing leadership for the conduct of clinical research for product approval, post-market clinical follow-up, and market adoption or development
• Ensuring research plans are scientifically valid, meeting regulatory requirements, and are conducted within ethical guidelines
• Ensuring audit readiness and participating in related activities, e.g., serving as a subject matter expert
• Setting and communicating strategy, direction, priorities, and goals in partnership with the CRMS Leadership Team
• Serving as the ENT Clinical Research representative for enterprise councils and communities of practice
• Creating and maintaining a culture of ownership and accountability
• Managing performance, developing talent, and fostering engagement and inclusion through 1:1s, feedback, coaching, and delegation
• Setting and maintaining the budget and resourcing for the clinical research program and team
• Advancing ways of working and operational efficiency, including the use of AI-enabled tools
• Communicating business and operational developments up, down, and across
• Preparing reports and presentations for internal and external stakeholders for projects and budgets, integrating information from multiple sources

Senior Clinical Research Manager

• Responsible for the overall management the studies assigned to you including administrative duties
• Responsible for clear and direct communication with study sponsor, study monitor and CRO, PI and site manager
• Manage the daily operations of assigned clinical trials.
• Communicate with the investigator, sponsor and study participants all necessary information of the study.
• Problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner.
• Inform study participants or caregivers about study procedures and outcomes to be expected
• Train study team members and monitor study activities to ensure compliance with protocols

Clinical Research Coordinator III

• You’ll own the day-to-day operational execution of assigned clinical studies and be accountable for quality, timelines, and partner relationships from protocol implementation through close-out.
• Implementing and maintaining primary accountability for clinical study protocols and operational plans aligned with corporate strategic objectives.
• Managing day-to-day study operations in compliance with GCP/ICH guidelines and applicable regulatory requirements.
• Coordinating study timelines across cross-functional teams to hit critical milestones, proactively identifying and resolving issues before they become blockers, and managing escalation when needed.
• Providing oversight and direction to study team members (CRAs, Project Coordination) on study deliverables and performance.
• Training partners, sites, and internal team members on study protocols, operational plans, and applicable guidelines and regulations.
• Co-developing and managing study materials through their full lifecycle- protocols, operational plans, and applicable guidelines and regulations.
• Overseeing the eTMF to ensure ongoing compliance and inspection readiness.
• Leading assigned internal and partner meetings, developing agendas, curating and filing minutes, and maintaining detailed dashboards and progress trackers that keep all stakeholders clearly informed.
• Supporting process improvement initiatives and serving as a subject matter expert and mentor within the clinical operations function.

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Clinical Research Coordinator II

Principal Clinical Research Specialist

Associate Clinical Trial Manager – Cardio, Renal, GI, Metabolic

Senior Clinical Research Manager

Clinical Research Coordinator III

Clinical Trial Manager