Clinical Study Manager, Sr.

Requisition ID:                       64091                          Title: Clinical Study Manager, Sr. Division: Arthrex, Inc. (US01) Location: INC- Naples, FL (US08)

 

 

 

 

 

 

 

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:

• Bachelor’s degree required.  Master’s degree preferred.
• 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
• Familiarity with orthopedics and medical terminology is preferred