Clinical Study Manager

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Artex Risk Solutions

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1997

💸 Finance

Finance • Insurance • Risk Management

Artex Risk Solutions is a leader in alternative risk management, providing innovative solutions for both large and small organizations. They specialize in creative risk management strategies that help clients optimize their cost of risk, leveraging expertise in capital solutions, specialty risk transfer, and carrier outsourcing services. With a global presence and a commitment to challenging traditional approaches, Artex aims to empower businesses to make informed risk management decisions and enhance their operational efficiency.

📋 Description

• 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

• 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

• 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)