Sr. Clinical Study Manager (Remote)

Requisition ID:                       65348                          Title: Sr. Clinical Study Manager (Remote)

 

 

Compensation: $100,000.00-$130,000.00 

 

 

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 developing, managing, and facilitating activities related to the conduct of Arthrex-sponsored clinical research studies. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

This is a fully remote opportunity.

 

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.
• Strong research and technical writing skills and ability to review protocols and agreements for accuracy.
• Ability to organize and manipulate large data sets.
• Proficiency in Microsoft Office programs.
• Clinical Research Certification required, or must be willing to obtain within 1 year of employment.

 

Knowledge and Skill Requirements/Specialized Courses an