Clinical Study Manager, Sr

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Clinical Study Manager. This individual will be responsible for leading and supporting clinical studies and projects aligned with Arthrex Research’s clinical research initiatives. The successful candidate will lead and oversee the full lifecycle of multicenter clinical studies, ensuring execution in compliance with research ethics, regulatory requirements, ISO standards, and internal procedures.

This individual will drive study strategy, site management, monitoring activities, budgets, and cross-functional collaboration while serving as a key decision-maker for study operations, amendments, and risk management. The role also provides leadership and mentorship to research staff, ensuring the successful delivery of clinical research projects and portfolio objectives. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Essential Duties and Responsibilities:

• Leading, planning, executing, managing, and oversight of clinical studies according to research ethics guidelines, ISO standards, internal SOPs, applicable regulations, and portfolio priorities.
• Leads the implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies.
• Responsible for IRB communication, including document preparation and submission of Arthrex study initiatives.
• Implementing modifications to optimize protocol results or edit/amend study documentation if necessary.
• Collaborate with Data Management team to ensure the electronic data capture system (EDC) is designed to collect all required data per the protocol.
• Responsible for training internal staff assigned to studies.
• Project lead for other research staff assigned to multicenter studies.
• Key decision maker for study amendments and strategies
• Maintain appropriate monitoring and maintenance of clinical sites to ensure the overall successful conduct of assigned clinical studies.
• Oversee all aspects of the assigned clinical projects, including essential documents, electronic data collection, change management, risk management, and monitoring activities.
• Set-up and maintain accurate progress and Site study status tracking logs to provide reports and updates of assigned clinical research projects.
• Oversee follow-up and lead query resolution with sites via ongoing interactions.
• Participation in investigator meetings, Site initiation, monitoring, and close-out visits when applicable
• Complete central, remote, and on-site monitoring reports and follow-up letters
• Complete monitoring report reviews of other staff
• Oversee monitoring activities for the assigned projects and is responsible for ensuring actions are taken when applicable.
• Identify and mitigate quality risk and/or issues associated with assigned studies/activities.
• Facilitate appropriate documentation to maintain compliance with the Finance and Compliance departments.
• Prepare and track clinical study budgets that include both sponsor costs and sites costs.
• Responsible for the timely completion of deliverables, inclusive of contributing to interim and final study reports
• Facilitate efficient utilization of available clinical data, addressing the needs of internal and external stakeholders (e.g., publications)
• Works closely with leadership, product management, medical writing, project manager, and other research staff to manage assigned studies.
• Conducts regular investigator meetings to ensure protocol compliance and site engagement.
• Actively participate in research committees, study groups, and cross-functional portfolio…