Title: Clinical Research Project Manager
Location: Naples, FL
**This position in based in Naples, FL. Remote optional for the right candidate. If remote, travel required to Naples headquarters quarterly for 1 week**
Arthrex is a global medical device company and leader in research, new product development and medical education in orthopedics. 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. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. Arthrex is actively searching for a Clinical Research Project Manager to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
The Clinical Research Project Manager is responsible for managing and resolving issues related to the time, budget, and resource allocation for clinical studies. The Clinical Research Project Manager will track timelines, developing budgets, oversee study progress, interacting with all aspects of the study team (data management, monitoring, medical writing, biostatistics, etc.).
Essential Duties and Responsibilities:
- Under supervision of direct manager, works to lead a project team conducting assigned clinical research studies.
- Moves project forward while ensuring quality, timelines, and budget management.
- Coordinates activities and deliverables with all study conduct partners and is accountable for all project deliverables for each project assigned.
- Prepares high-level budget estimates in response to internal study requests followed by detailed budget proposals.
- Ensures accurate trial budget management, updates for scope changes, and reconciliation of assigned trials.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
- When necessary, escalates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams, business partners, and clinical research leadership.
- Ensures accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines.
- Development and implementation of project plans.
- Prepare project management reports for research management.
- Expected to be proactive in managing projects and in communications with key stakeholders around attaining project goals, deliverables, timelines, budget, and quality
- Utilizes Workfront templates/processes and other tools for work management
- Works to improve processes and solve routine problems of limited scope and complexity following established policies and procedure
Education and Experience:
- 5 years of clinical research experience is required.
- 1 year project management experience required.
- Bachelor’s Degree required, preferably in life sciences or another relevant field.
- Experience working for a medical device manufacturer, pharmaceutical manufacture, or clinical research organization (CRO) is required.
- Direct orthopedic therapeutic area expertise is preferred.
- Experience with multiple study types, including real-world evidence (RWE), post-marketing, interventional, and observational is preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Strong knowledge of Good Clinical Practice/ICH guidelines and applicable regulatory and ethical requirements.
- Strong organizational skills and ability to manage time and work independently.
- Ability to embrace new technologies.
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- Strong technology skills in project management and clinical trial software.
- Ability to effectively communicate project planning requirements to all stakeholders, including task assignments, duration, and resource requirements.
- Strong strategic thinker, excellent collaboration, and careful attention to detail.
- Awareness of orthopedic surgery principles, theories, and products preferred.
- Strong accountability to project deliverable timing and budgets required.
- Continuously seeking ways to improve complex systems of people and processes
Machine, Tools, and/or Equipment Skills:
- PC, database, research tools, internet research tools.
- All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
To apply for this position or to learn more, please click "Apply Online" below.
SOCRA Exp: 9/10/2022