Clinical Affairs Manager
Clinical Affairs Manager
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Job Description
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 Investigators 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 Partand 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)
Bachelors 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).
Required Experience:
Manager
Employment Type
Full-Time
