Clinical Study Manager

Requisition

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.

• 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 audits 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 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.

• 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…