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 and/or Training:

• 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.

Machine, Tools, and/or Equipment Skills:

• Computer experience in Microsoft Office is required.

Reasoning Ability:

• Ability to define and identify problems and seek opportunities to resolve/improve these issues. 
• Interpret policies and procedures; identify non-compliance and take appropriate action.

Language and Communication Skills:

• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

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 Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

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.