Sr. Clinical Study Manager

Essential Duties and Responsibilities

• Leading, planning, executing, managing, and overseeing the conduct of clinical research studies according to research ethics guidelines, ISO standards, internal SOPs, applicable regulations, and portfolio priorities. - Implementation of clinical protocols, informed consent forms, and study-related materials. - Management of site initiation activities (e.g., study start-up documentation). - Communication with Institutional Review Boards (IRBs) for document preparation and submission. - Implementation of modifications to optimize protocol results or amend study documentation. - Collaboration with Data Management team to ensure EDC is designed for all required data per the protocol. - Training of internal staff assigned to studies. - Project lead for other research staff assigned to multicenter studies. - Decision making for study amendments and strategies. - Monitoring and maintaining clinical sites to ensure the successful conduct of assigned clinical studies. - Oversight of all aspects of assigned clinical projects, including essential documents, electronic data collection, change management, risk management, and monitoring activities. - Setting up and maintaining accurate progress and site study status tracking logs to provide reports and updates of assigned clinical research projects. - Overseeing follow-up and resolving queries with sites through ongoing interactions. - Participation in investigator meetings, site initiation, monitoring, and close-out visits when applicable. - Completion of central, remote, and on-site monitoring reports and follow-up letters. - Completion of monitoring report reviews of other staff. - Overseeing monitoring activities for assigned projects and ensuring actions are taken when necessary. - Identifying and mitigating quality risks and/or issues associated with assigned studies/activities. - Facilitating appropriate documentation to maintain compliance with Finance and Compliance departments. - Preparation and tracking of clinical study budgets that include both sponsor and site costs. - Ensuring timely completion of deliverables, including contributing to interim and final study reports. - Facilitating efficient utilization of available clinical data, addressing the needs of internal and external stakeholders (e.g., publications). - Working closely with leadership, product management, medical writing, project manager, and other research staff to manage assigned studies. - Conducting regular investigator meetings to ensure protocol compliance and site engagement. - Actively participating in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment. - Engaging in and supporting departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achieving key business outcomes. - Conducting project huddles and leading cross-functional projects. - Mentoring and training staff.

Knowledge and Skill Requirements/Specialized Courses and/or Training

• Strong strategic thinking with the ability to translate goals into actionable project plans. - Understanding of cross-functional clinical study processes. - Teamwork, good communication, documentation, and strong understanding of data collection and analytical processes. - Ability to identify a research hypothesis and proposed outcome measures. - Basic understanding of surgical techniques and the instruments necessary to perform procedures. - Effective communication with physicians, key opinion leaders, and other 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. - Experience in post-market, real-world evidence, longitudinal, or health economics studies. - Ability to generate and develop ideas that drive efficiency and impact organizational goals. - Innovative, solution-oriented mindset to approach challenges.

Education and Experience

• Bachelor’s degree required. Master’s degree preferred. - Six 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 one 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 Program - Trip of a Lifetime - Paid Parental Leave - Paid Time Off - Volunteer PTO - Employee Assistance Provider (EAP)