Clinical Study Manager, Sr.

Essential Duties and 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.

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.
• 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 a 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 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.
• 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.