{"id":3332537,"url":"https://alion.io/job/arthrex-sr-clinical-study-manager","title":"Sr. Clinical Study Manager","company":{"id":12664,"name":"Arthrex","domain":"arthrex.com","url":"https://alion.io/company/arthrex","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":98,"open_postings":13,"ghost_share":0,"stale_share":0.077,"repost_share":0,"time_to_fill_p50_days":22,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Naples, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":79000,"max_usd":138000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":356},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-15T02:00:00Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-11-01T21:40:53Z","board_verified":true,"closed_at":null,"days_open":17,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":17},"description":"Requisition ID:\n67724 \n\nTitle:\nSr. Clinical Study Manager\n\nArthrex, 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 and supporting clinical studies and projects aligned with Arthrex Research’s clinical research initiatives. The successful candidate will lead and oversee the full lifecycle of multicenter clinical studies, ensuring execution in compliance with research ethics, regulatory requirements, ISO standards, and internal procedures. This individual will drive study strategy, site management, monitoring activities, budgets, and cross-functional collaboration while serving as a key decision-maker for study operations, amendments, and risk management. The role also provides leadership and mentorship to research staff, ensuring the successful delivery of clinical research projects and portfolio objectives. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.\nEssential Duties and Responsibilities:\nLeading, planning, executing, managing, and oversight of clinical studies according to research ethics guidelines, ISO standards, internal SOPs, applicable regulations, and portfolio priorities.\nLeads the implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies.\nManages site initiation activities (e.g., study start-up documentation preparation)\nResponsible for IRB communication, including document preparation and submission of Arthrex study initiatives.\nImplementing modifications to optimize protocol results or edit/amend study documentation if necessary.\nCollaborate with Data Management team to ensure the electronic data capture system (EDC) is designed to collect all required data per the protocol.\nResponsible for training internal staff assigned to studies.\nProject lead for other research staff assigned to multicenter studies. \nKey decision maker for study amendments and strategies\nMaintain appropriate monitoring and maintenance of clinical sites to ensure the overall successful conduct of assigned clinical studies.\nOversee all aspects of the assigned clinical projects, including essential documents, electronic data collection, change management, risk management, and monitoring activities. \nSet-up and maintain accurate progress and Site study status tracking logs to provide reports and updates of assigned clinical research projects. \nOversee follow-up and lead query resolution with sites via ongoing interactions.\nParticipation in investigator meetings, Site initiation, monitoring, and close-out visits when applicable\nComplete central, remote, and on-site monitoring reports and follow-up letters \nComplete monitoring report reviews of other staff\nOversee monitoring activities for the assigned projects and is responsible for ensuring actions are taken when applicable. \nIdentify and mitigate quality risk and/or issues associated with assigned studies/activities. \nFacilitate appropriate documentation to maintain compliance with the Finance and Compliance departments.\nPrepare and track clinical study budgets that include both sponsor costs and sites costs.\nResponsible for the timely completion of deliverables, inclusive of contributing to interim and final study reports\nFacilitate efficient utilization of available clinical data, addressing the needs of internal and external stakeholders (e.g., publications)\nWorks closely with leadership, product management, medical writing, project manager, and other research staff to manage assigned studies. \nConducts regular investigator meetings to ensure protocol compliance and site engagement.\nActively participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment\nEngage in and support departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achievement of key business outcomes.\nConducts project huddles and able to lead cross-functional projects.\nMentoring and training staff.\nServe 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.\nKnowledge and Skill Requirements/Specialized Courses and/or Training:\nStrong strategic thinking with the ability to translate goals into actionable project plans.\nAn understanding of cross-functional clinical study processes is required. \nAbility to work in a team, good communication, documentation, and a strong understanding of data collection and analytical processes are required. \nThe ability to identify a research hypothesis and proposed outcome measures to address the hypothesis is required. \nThe ability to read a surgical technique and have a basic understanding of the instruments necessary to perform the procedure is required. \nAble to communicate effectively with physicians, key opinion leaders, and other healthcare personnel. \nMust have a strong understanding of federal regulations relating to clinical studies (FDA, MDR), ISO, and research ethics. \nExperience in managing research contracts and protocol development is preferred.\nExperience in post-market, real world evidence, longitudinal or health economics studies is preferred.\nAbility to generate and develop ideas that drive efficiency and impact organizational goals.\nAbility to approach challenges with an innovative, solution-oriented mindset.\nEducation and Experience:\nBachelor’s degree required. Master’s degree preferred.\n6 plus years of related clinical research experience required. \nThree-year Sponsor/CRO preferred. Preferably, in a medical device industry environment \nOne year of clinical research monitoring or study manager experience required.\nFamiliarity with orthopedics and medical terminology is preferred.\nStrong research and technical writing skills and ability to review protocols and agreements for accuracy. \nAbility to organize and review data sets\nProficiency in Microsoft Office programs \nClinical Research Certification required or must be willing to obtain within 1 year of employment. \nArthrex Benefits\nMedical, Dental and Vision Insurance\nCompany-Provided Life Insurance\nVoluntary Life Insurance\nFlexible Spending Account (FSA)\nSupplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)\nMatching 401(k) Retirement Plan\nAnnual Bonus\nWellness Incentive Program\nFree Onsite Medical Clinics\nFree Onsite Lunch\nTuition Reimbursement Program\nTrip of a Lifetime\nPaid Parental Leave\nPaid Time Off\nVolunteer PTO\nEmployee Assistance Provider (EAP)\nAll 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.","description_format":"text","description_chars":7061,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Life insurance","Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Surgical Instruments & Devices","Orthopedic & Spine Implants","Medical Education & Training"],"lifecycle":[{"event":"open","at":"2026-10-27T12:25:09Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 19 · green card filings: 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