Sr. Clinical Study Manager

Arthrex; Naples (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Flexible Spending Account (FSA)

Tuition reimbursement

Paid parental leave

Annual bonus

Job summary

Arthrex, based in Naples, Florida, is seeking a Sr. Clinical Study Manager to lead and oversee clinical research studies. This role is critical for managing study protocols, ensuring compliance with regulations, and facilitating effective communication among stakeholders.

The ideal candidate will have a Bachelor's degree, extensive clinical research experience, and the ability to mentor staff and drive project outcomes. Benefits include medical insurance, a 401(k) plan, and tuition reimbursement.

Qualifications

• Minimum of 6 years of clinical research experience required.
• One year of clinical research monitoring or study management experience is required.
• Clinical Research Certification is required or should be obtained within 1 year.

Responsibilities

• Lead and manage clinical studies according to guidelines.
• Oversee site initiation activities and maintain compliance.
• Collaborate with data management for effective data collection.

Skills

Strategic thinking

Effective teamwork

Data collection skills

Regulatory compliance knowledge

Communication with healthcare personnel

Education

Bachelor's degree

Master's degree (preferred)

Tools

Microsoft Office

Job description

Overview

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 leading, developing, managing, and facilitating activities related to the conduct of clinical research studies.

Requisition ID: 66722

Essential Duties And Responsibilities

• Lead, plan, execute, manage, and oversee clinical studies according to research ethics guidelines, ISO standards, internal SOPs, applicable regulations, and portfolio priorities.
• Lead the implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies.
• Manage site initiation activities (e.g., study start-up documentation preparation).
• Responsible for IRB communication, including document preparation and submission of Arthrex study initiatives.
• Implement modifications to optimize protocol results or edit/amend study documentation if necessary.
• Collaborate with Data Management to ensure the electronic data capture system (EDC) is designed to collect all required data per the protocol.
• Provide training for internal staff assigned to studies.
• Serve as project lead for other research staff assigned to multicenter studies.
• Act as key decision maker for study amendments and strategies.
• Maintain appropriate monitoring and maintenance of clinical sites to ensure successful conduct of assigned studies.
• Oversee all aspects of 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.
• Oversee follow-up and lead query resolution with sites via ongoing interactions.
• Participate in investigator meetings, site initiation, monitoring, and close-out visits when applicable.
• Complete central, remote, and on-site monitoring reports and follow-up letters; review monitoring reports of other staff.
• Oversee monitoring activities and ensure 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 Finance and Compliance departments.
• Prepare and track clinical study budgets including sponsor costs and sites costs.
• Ensure timely completion of deliverables, including interim and final study reports.
• Facilitate efficient utilization of available clinical data for internal and external stakeholders (e.g., publications).
• Collaborate with leadership, product management, medical writing, project management, and other research staff to manage assigned studies.
• Conduct regular investigator meetings to ensure protocol compliance and site engagement.
• Participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment.
• Engage in departmental initiatives and cross-functional projects, driving execution and problem-solving to achieve key business outcomes.
• Lead cross-functional projects, conduct project huddles, and mentor/train staff.
• Serve as a cross-functional lead within an assigned study and product portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other stakeholders.

Knowledge And Skill Requirements

• Strong strategic thinking with the ability to translate goals into actionable project plans.
• Understanding of cross-functional clinical study processes.
• Effective teamwork, communication, documentation, and data collection/analytical skills.
• Ability to identify a research hypothesis and proposed outcome measures.
• Ability to read a surgical technique and understand instruments required for the procedure.
• Effective communication with physicians, key opinion leaders, and healthcare personnel.
• Strong understanding of federal regulations relating to clinical studies (FDA, MDR), ISO, and research ethics.
• Experience in managing research contracts and protocol development is preferred.
• Experience in post-market, real-world evidence, longitudinal, or health economics studies is preferred.
• Ability to generate ideas that drive efficiency and impact organizational goals; solution-oriented mindset.

Education And Experience

• Bachelor’s degree required; Master’s degree preferred.
• 6+ years of related clinical research experience.
• Three-year Sponsor/CRO experience preferred; preferably in a medical device environment.
• One year of clinical research monitoring or study management experience required.
• Familiarity with orthopedics and medical terminology preferred.
• Strong research and technical writing skills; ability to review protocols and agreements for accuracy.
• Ability to organize and review data sets.
• Proficiency in Microsoft Office.
• Clinical Research Certification required or willing to obtain within 1 year of employment.

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
• Paid parental leave
• Paid time off
• Volunteer PTO
• Employee Assistance Program (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.