Clinical Study Manager

Artex Risk Solutions

Clinical Study Manager leading and supporting clinical studies in a global medical device company. Focused on orthopedic research and helping surgeons treat their patients better.

Posted 6/25/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $84,000 - $110,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

clinical researchdata managementelectronic data captureCRF designeTMF designCTMS designprotocol developmentmonitoring visitsrisk managementCAPA plans

Soft Skills

strategic thinkingcommunicationdocumentationrecord-keepingproblem-solvingcollaborationproject managementcross-functional leadershiptraining facilitationstakeholder engagement

Certifications & Qualifications

Clinical Research Certification

Industry Keywords

orthopedic terminologyISO standardsresearch ethicsIRB approvalHCP transfers of valueclinical contract agreementspost-market studiesreal world evidencelongitudinal studieshealth economics studies

About the role

Key responsibilities & impact

Planning, executing, managing, and oversight of clinical studies and projects according to Research ethics guidelines, ISO standards, internal SOPs, and portfolio priorities
Serve as a cross-functional lead within an assigned study portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other key stakeholders
Provide accurate, timely status reports and portfolio-level updates on assigned clinical research studies and projects
Facilitate appropriate documentation to maintain compliance with the AP and Compliance department for HCP transfers of value
Facilitate clinical contract agreements between Arthrex and the Site for studies
Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies
Provide centralized communication and coordination between research sites and internal cross-functional stakeholders
Facilitate site training for data collection clinical research initiatives
Monitor data collection compliance and communicate with sites to optimize data collection
Provide the main line of communication with research sites
Facilitate IRB approval at the site and sponsor level
Oversee and approve site activation activities for studies, ensuring readiness across all functional areas
Collaborate on reviewing protocols, case report forms, and informed consent for clinical studies
Qualify sites for participation in assigned studies
Complete central, remote, and on-site monitoring visits, reports, and follow-up letters
Identify study- and portfolio-level risks or issues, implement mitigation strategies, and develop CAPA plans as appropriate
Works closely with the other clinical research professionals and cross-functional partners to ensure successful study execution
Conduct 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

Requirements

What you’ll need

Bachelor’s degree required
4 years of relevant clinical research experience required
Familiarity with orthopedic terminology is preferred
One year of industry sponsor or CRO employment preferred
Clinical Research Certification required, or must be willing to obtain within 1 year of employment
Strong strategic thinking with the ability to translate goals into actionable project plans
An understanding of cross-functional clinical study processes is required
Good communication, documentation, and record-keeping skills are required
Experience managing research contracts and protocol development is preferred
Able to communicate effectively with physicians, key opinion leaders, and other healthcare personnel
Experience in post-market, real world evidence, longitudinal or health economics studies is preferred

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
Gym Reimbursement Program
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)