Clinical Study Manager

Requisition ID: 65832 Title: Clinical Study Manager

Arthrex, 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 Clinical Study Manager to support clinical research studies. This individual will be responsible for assisting the study team in running the day to day operational activities within clinical studies. The ideal candidate would have experience managing clinical research studies from start‑up through close‑out, overseeing site operations, CRO activities, data collection, investigational product management, and compliance across CTMS, eTMF, and EDC systems. They would also lead contract and budget negotiations, vendor onboarding, site training, and regulatory coordination while tracking timelines, milestones, and quality metrics to ensure successful study execution. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Essential Duties and Responsibilities:

• Manage clinical research studies from intake through closeout.
• Monitor the management of and collection of data.
• Ensures compliance with the Clinical Trial Management System (CTMS), Electronic Trial Master (eTMF) filing, and Electronic Data Capture (EDC) systems, securing essential documents and quality-checking files and the EDC for accuracy and completeness.
• Responsible for securing essential vendor documents for assigned clinical studies to assist in establishing accounts in A/P system within compliance guidelines.
• Responsible for establishing accounts in billing systems within compliance guidelines and issuing payments to vendors and investigators according to executed agreements.
• Lead clinical trial agreement negotiations to ensure efficient and timely processing of clinical trial agreements.
• Provides oversight for Contract Research Organizations (CRO) activities.
• Lead clinical budget negotiations for the purpose of executing a clinical study.
• Tracks study status, enrollment, regulatory documentation, and site start-up status and communicates status with the study sites.
• Track and report on the progress of assigned clinical studies, including budget and timelines.
• Responsible for ordering, distributing, and receiving investigational products.
• Assists in user acceptance testing in the EDC and eTMF; evaluates new database updates.
• Assists with the preparation of technical reports, summaries, templates, and protocols.
• Oversee data collection compliance via tracked milestones.
• Orders, distributes and tracks study supplies and assists the study team in developing study-related documents.
• Maintains all pertinent study correspondences between the sponsor, study sites, and third parties.
• Develops clinical research standard operating procedures and work instructions.
• Coordinate and lead Investigational site training and meetings.
• Identify and mitigate quality risk and/or issues associated with assigned studies/activities.
• Assist site coordinators with IRB submissions as necessary.
• Ensure operational aspects of the studies being conducted in accordance with all relevant ethical and government standards, GCP's, and Standard Operating Procedures.
• Participate in the preparation and follow-up of internal process audits, vendor and study site quality auditis as well as regulatory inspections.
• Keep management and Arthrex stakeholders informed on the progress of assigned clinical study metrics and other project-related information. Specifically, costs, timelines, milestones, and other pertinent metrics.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Knowledge of ICH guidelines and FDA Regulations relevant to clinical studies is required.
• Clinical Research Certification is required or obtained in one year.
• Comprehension of medical terminology or can reference literature for understanding.
• Proficient software skills: Word/ Excel/PowerPoint/database.
• A combination of education, experience, and RA influence may be considered.

Education and Experience:

• Bachelor's degree in health, life sciences or other relevant field of study + 4 years of Clinical Research experience required OR Master's Degree + 5 years experience.
• Pre-market IDE or IND study experience preferred.
• One year of industry-sponsored or CRO employment is required.

Incidental Duties:

• The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed, additional responsibilities may be assigned, as required, by management.

Machine, Tools, and/or Equipment Skills:

• PC, database, research tools, internet research tools.

Language and Communication Skills:

• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Ability to write clearly and succinctly; must be able to accurately record meeting minutes, action items, draft procedures, business correspondence, reports, and presentations.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.

Arthrex 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)

All 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.