Senior Clinical Study Manager

Jobtailor; Naples (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor in the United States is seeking an experienced Clinical Study Manager to lead multicenter trials, ensuring compliance with ethics guidelines, ISO standards, and sponsor requirements. You will plan, execute, and oversee study activities from start-up to close-out.

You will manage site initiation, IRB submissions, data capture design, and cross-functional collaboration with Data Management, Regulatory, and Medical Writing.

Qualifications

• Bachelor’s degree required.
• Master’s degree preferred.
• 6+ years of related clinical research experience required.
• 3-year Sponsor/CRO preferred; preferably in a medical device environment.
• 1 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.

Responsibilities

• 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.

Skills

Orthopedics terminology

Data organization

Research writing

Education

Bachelor's degree

Master's degree

Clinical Research Certification

Tools

Microsoft Office

Job description

Responsibilities

• 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

• 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.