Clinical Study Manager (Remote)

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 Clinical Study Manager. This individual will be responsible for leading and supporting clinical studies and projects aligned with Arthrex Research’s clinical research initiatives. 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:

• Planning, executing, managing, and oversight of clinical studies and projects according to Research ethics guidelines, ISO standards, internal SOPs, and portfolio priorities.
• Serve as a cross-functional lead within an assigned study portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other key stakeholders.
• Provide accurate, timely status reports and portfolio-level updates on assigned clinical research studies and projects.
• Facilitate appropriate documentation to maintain compliance with the AP and Compliance department for HCP transfers of value.
• Facilitate clinical contract agreements between Arthrex and the Site for studies.
• Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies.
• Provide centralized communication and coordination between research sites and internal cross-functional stakeholders.
• Facilitate site training for data collection clinical research initiatives.
• Monitor data collection compliance and communicate with sites to optimize data collection.
• Provide the main line of communication with research sites.
• Facilitate IRB approval at the site and sponsor level.
• Oversee and approve site activation activities for studies, ensuring readiness across all functional areas.
• Collaborate on reviewing protocols, case report forms, and informed consent for clinical studies.
• Qualify sites for participation in assigned studies.
• Complete central, remote, and on-site monitoring visits, reports, and follow-up letters.
• Identify study- and portfolio-level risks or issues, implement mitigation strategies, and develop CAPA plans as appropriate.
• Works closely with the other clinical research professionals and cross-functional partners to ensure successful study execution.
• Conduct regular investigator meetings to ensure protocol compliance and site engagement.
• Actively participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment.
• Engage in and support departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achievement of key business outcomes.

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

• Strong strategic thinking with the ability to translate goals into actionable project plans.
• An understanding of cross-functional clinical study processes is required.
• Good communication, documentation, and record-keeping skills are required.　
• Ability to identify a research hypothesis and proposed outcomes measures to address the hypothesis is required.
• Ability to read surgical techniques and have a basic understanding of the medical devices necessary to perform the procedure is required.
• Experience managing research contracts and protocol development is preferred.
• Able to communicate effectively with physicians, key opinion leaders, and other healthcare personnel.
• Experience in post-market, real world evidence, longitudinal or health economics studies is preferred.
• Ability to generate and develop ideas that drive efficiency and impact organizational goals.
• Ability to approach challenges with an innovative, solution-oriented mindset.

Education and Experience:

• Bachelor’s degree required.
• 4 years of relevant clinical research experience required.
• Familiarity with orthopedic terminology is preferred.
• One year of industry sponsor or CRO employment preferred.
• Clinical Research Certification required, or must be willing to obtain within 1 year of employment.

Machine, Tools, and/or Equipment Skills:

• Experience in Microsoft Office, Clinical trial Electronic Data Capture systems, and electronic trial master file is required.
• Experience in clinical trial management systems is preferred.

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
• Gym Reimbursement Program
• 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.