Arthrex · 1 day ago
Clinical Study Manager, Sr.
Naples, FL
Full-time
Onsite
Senior Level
6+ years expArthrex is a global medical device company and leader in orthopedics medical education. They are seeking a Senior Clinical Study Manager to develop, manage, and facilitate activities related to the conduct of Arthrex-sponsored clinical research studies.
Health CareMedical Device
Responsibilities
Initiate clinical research for Arthrex-sponsored studies
Planning, executing, managing, and oversight of clinical studies
Leads the implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies
Manages site initiation activities (e.g., study start-up documentation preparation)
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
Assists with ensuring the electronic data capture system (EDC) is designed to collect all required data per the protocol
Responsible for training internal staff assigned to studies
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
Responsible for the timely completion of deliverables, inclusive of analysis of large data sets/spreadsheets using Excel or other applications for interim study status reporting to meet Arthrex and research goals
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
Execute clinical studies according to ICH/GCP guidelines, ISO guidelines, and internal SOPs
Qualification
Required
Bachelor's degree required
6 plus years of related clinical research experience required
Minimum three-year Sponsor/CRO required. Preferably, in a medical device industry environment
One year of clinical research monitoring or study manager experience required
Clinical Research Certification required, or must be willing to obtain within 1 year of employment
An understanding of cross-functional clinical study processes is required
Ability to work in a team, good communication, documentation, and a strong understanding of data collection and analytical processes are required
The ability to identify a research hypothesis and proposed outcome measures to address the hypothesis is required
The ability to read a surgical technique and have a basic understanding of the instruments necessary to perform the procedure is required
Able to communicate effectively with physicians, key opinion leaders, and other healthcare personnel
Must have an understanding of institutional, state, and federal regulations relating to clinical studies, Good Clinical Practice (GCP), and research ethics
Experience in managing research contracts and protocol development is required
Computer experience in Microsoft Office is required
Preferred
Master's degree preferred
Familiarity with orthopedics and medical terminology is preferred
Strong research and technical writing skills and ability to review protocols and agreements for accuracy
Ability to organize and manipulate large data sets
Benefits
Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Company
Arthrex
Arthrex is a global medical device company and leader in new product development and medical education in orthopedics.
10001+ employees
H1B Sponsorship
Arthrex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (22)
2023 (13)
2022 (13)
2021 (9)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
Eric Butler
Sr. Director - Surgical Imaging & Integration
Kazu Miyahara
Senior Engineering Manager
Recent News
2025-12-24
Company data provided by crunchbase