Clinical Study Manager, Sr.

Arthrex • Naples, FL

75d

About The Position

Arthrex is a global medical device company and leader in orthopedics medical education. With a corporate mission of Helping Surgeons Treat Their Patients Better, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. Arthrex is actively searching for a Sr. Clinical Study Manager. The successful candidate will work alongside a department of expert orthopedic healthcare professionals, world class faculty, and product management. The main objective is to develop, manage, and facilitate activities related to the conduct of Arthrex-sponsored clinical research studies.

Requirements

• Bachelor's degree required. Master's degree preferred.
• 6 plus years of related clinical research experience required.
• Minimum three-year Sponsor/CRO required. 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 manipulate large data sets
• Proficiency in Microsoft Office programs
• Clinical Research Certification required, or must be willing to obtain within 1 year of employment

Nice To Haves

• 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 an understanding of institutional, state, and federal regulations relating to clinical studies, Good Clinical Practice (GCP), and research ethics
• Experience in managing research contracts and protocol development is required.

Responsibilities

• Initiate clinical research for Arthrex-sponsored studies
• Planning, executing, managing, and oversight of clinical studies
• 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
• Assists with ensuring the electronic data capture system (EDC) is designed to collect all required data per the protocol
• Responsible for training internal staff assigned to studies
• 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
• Responsible for the timely completion of deliverables, inclusive of analysis of large data sets/spreadsheets using Excel or other applications for interim study status reporting to meet Arthrex and research goals
• 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
• Execute clinical studies according to ICH/GCP guidelines, ISO guidelines, and internal SOPs

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees