Job Title: Clinical Affairs Manager

Department: Clinical

Direct Manager: V.P. Regulatory, Clinical & Quality

Office Location: Remote role - May sit anywhere in the US 

Job Summary:

This Clinical Affairs Manager is responsible for leading the planning, execution, and oversight of clinical investigations for Class III and Class II medical devices, with a specific focus on carotid stents. This role will work cross-functionally to develop clinical strategies that align with regulatory, quality, and business objectives. Responsibilities include protocol development, site and vendor management, clinical trial execution, regulatory submissions support (e.g., IDE, PMA), and post-market clinical follow-up as applicable.

Essential Duties and Responsibilities

· Lead the development and execution of Clinical Study Plans, including timelines, budget forecasts, risk mitigation strategies, site and patient recruitment plans, monitoring strategy, and communication plans.

· Author and review clinical protocols, Investigator’s Brochure (IB), Informed Consent Forms (ICF), Case Report Forms (CRFs), and other essential study documents in collaboration with internal and external stakeholders.

· Provide strategic input and author content for regulatory submissions (e.g., Pre-IDE, IDE, PMA, Annual Reports).

· Manage and/or oversee clinical vendors (e.g., CROs, imaging core labs, data management, biostatistics), including evaluation, selection, contract negotiation, and performance management.

· Lead cross-functional team meetings and provide regular clinical trial updates to management and other stakeholders.

· Ensure clinical trials are conducted in compliance with applicable FDA regulations (21 CFR Part 812, 50, 54, and 56), ICH-GCP, ISO 14155, and internal SOPs.

· Develop and oversee site training, monitoring oversight plans, and ensure proper documentation and data quality throughout the study.

· Drive resolution of study-related issues, including patient safety concerns, data discrepancies, and protocol deviations.

· Support clinical strategy development for regulatory and market access purposes, including pre-submissions and advisory panel preparation.

· Collaborate with Marketing and Medical Affairs to provide clinical input on promotional materials and scientific publications.

· Participate in Clinical Events Committees (CEC) or Data Monitoring Committees (DMC) where required.

· Oversee or contribute to Post-Market Clinical Follow-Up (PMCF) studies, registries, or Real-World Evidence (RWE) collection.

Requirements (Relevant Education/ Languages, Skills)

· Bachelor’s degree in a scientific or health-related field (e.g., life sciences, biomedical engineering, nursing).

· 10+ years of clinical research experience in medical device clinical affairs (preferably Class III).

· Demonstrated experience managing clinical trials from protocol development through study closeout.

· Solid understanding of FDA regulations, IDE/PMA pathways, and clinical requirements for implantable devices.

· Excellent communication, organizational, and leadership skills.

· Ability to travel up to 20%, including to clinical sites, investigator meetings, and conferences.

Preferred Requirements:

· Advanced degree (MS, MPH, PhD, or equivalent) in a life science discipline.

· Experience in vascular or neurovascular space (e.g., carotid, peripheral, or intracranial stenting).

· Experience in clinical quality systems, including CAPA, audit support, and SOP development.

· Strong background in clinical operations and vendor oversight.

· Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).