Senior Clinical Study Manager

Artex Risk Solutions

Leading clinical research studies at Arthrex, a global medical device company focused on orthopedic innovation. Managing and facilitating activities related to clinical research studies and collaboration with cross-functional teams.

Posted 7/2/2026full-timeNaples • Florida • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading and managing clinical studies, ensuring compliance with research ethics, ISO standards, and regulatory requirements. Proficient in clinical protocol implementation, data management collaboration, and effective communication with stakeholders.

Highest-signal resume keywords

Clinical Research CertificationClinical Study ManagementData Management CollaborationTechnical Writing SkillsRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Protocol ImplementationStudy Documentation PreparationSite Initiation ActivitiesMonitoring Report ReviewsBudget Preparation and TrackingData Set OrganizationChange ManagementQuality Risk IdentificationClinical Research MonitoringRegulatory Compliance

Soft Skills

LeadershipMentoringCollaborationProblem-SolvingCommunication

Tools & Technologies

Electronic Data Capture SystemMicrosoft Office

Certifications & Qualifications

Clinical Research Certification

Industry Keywords

Clinical StudiesISO StandardsMedical Device IndustryOrthopedicsInformed Consent Forms

About the role

Key responsibilities & impact

Leading, planning, executing, managing, and oversight of clinical studies according to research ethics guidelines, ISO standards, internal SOPs, applicable regulations, and portfolio priorities.
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.
Collaborate with Data Management team to ensure the electronic data capture system (EDC) is designed to collect all required data per the protocol.
Responsible for training internal staff assigned to studies.
Project lead for other research staff assigned to multicenter studies.
Key decision maker for study amendments and strategies.
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 that include both sponsor costs and sites costs.
Responsible for the timely completion of deliverables, inclusive of contributing to interim and final study reports.
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.
Conducts 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.
Conducts project huddles and able to lead cross-functional projects.
Mentoring and training 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 key stakeholders.

Requirements

What you’ll need

Bachelor’s degree required
Master’s degree preferred
6 plus years of related clinical research experience required
Three-year Sponsor/CRO preferred. 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 review data sets
Proficiency in Microsoft Office programs
Clinical Research Certification required or must be willing to obtain within 1 year of employment.

Benefits

Comp & perks

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)