Sr. Clinical Study Manager

Overview

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, developing, managing, and facilitating activities related to the conduct of clinical research studies.

Requisition

• Lead, plan, execute, manage, and oversee clinical studies according to research ethics guidelines, ISO standards, internal SOPs, applicable regulations, and portfolio priorities.
• Lead the implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies.
• Manage site initiation activities (e.g., study start-up documentation preparation).
• Responsible for IRB communication, including document preparation and submission of Arthrex study initiatives.
• Implement modifications to optimize protocol results or edit/amend study documentation if necessary.
• Collaborate with Data Management to ensure the electronic data capture system (EDC) is designed to collect all required data per the protocol.
• Provide training for internal staff assigned to studies.
• Serve as project lead for other research staff assigned to multicenter studies.
• Act as key decision maker for study amendments and strategies.
• Maintain appropriate monitoring and maintenance of clinical sites to ensure successful conduct of assigned studies.
• Oversee all aspects of 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.
• Oversee follow-up and lead query resolution with sites via ongoing interactions.
• Participate in investigator meetings, site initiation, monitoring, and close-out visits when applicable.
• Complete central, remote, and on-site monitoring reports and follow-up letters; review monitoring reports of other staff.
• Oversee monitoring activities and ensure 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 Finance and Compliance departments.
• Prepare and track clinical study budgets including sponsor costs and sites costs.
• Ensure timely completion of deliverables, including interim and final study reports.
• Facilitate efficient utilization of available clinical data for internal and external stakeholders (e.g., publications).
• Collaborate with leadership, product management, medical writing, project management, and other research staff to manage assigned studies.
• Conduct regular investigator meetings to ensure protocol compliance and site engagement.
• Participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment.
• Engage in departmental initiatives and cross-functional projects, driving execution and problem-solving to achieve key business outcomes.
• Lead cross-functional projects, conduct project huddles, and mentor/train staff.
• Serve as a cross-functional lead within an assigned study and product portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other stakeholders.

• Strong strategic thinking with the ability to translate goals into actionable project plans.
• Understanding of cross-functional clinical study processes.
• Effective teamwork, communication, documentation, and data collection/analytical skills.
• Ability to identify a research hypothesis and proposed outcome measures.
• Ability to…