Clinical Study Manager, Sr.

Arthrex • Pelican Bay, FL

73d

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: Mid Level
• Education Level: Bachelor's degree