Senior Clinical Study Manager
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Naples • Florida • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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
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
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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchclinical protocolsinformed consent formselectronic data capture (EDC)data analysisdata manipulationmonitoring reportsrisk managementbudget preparationtechnical writing
Soft skills
leadershipcommunicationorganizationproblem-solvingcollaborationtrainingoversightquery resolutionadaptabilityattention to detail
Certifications
Clinical Research Certification