Clinical Study Manager, Sr.

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

Arthrex 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 Lunch

Tuition Reimbursement Program

Trip of a Lifetime

Paid Parental Leave

Paid Time Off

Volunteer PTO

Employee Assistance Provider (EAP)

Please note, most benefits are for regular, full time employees.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Arthrex is a global medical device company and leader in orthopedics medical education. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. Arthrex is actively searching for a Sr. Clinical Study Manager. The successful candidate will work alongside a department of expert orthopedic healthcare professionals, world class faculty, and product management.

Main Objective :

To develop, manage, and facilitate activities related to the conduct of Arthrex-sponsored clinical research studies.

Essential Duties and 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

Education and Experience :

Knowledge and Skill Requirements / Specialized Courses and / or Training :

Machine, Tools, and / or Equipment Skills :

Computer experience in Microsoft Office is required

Arthrex Benefits

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.