Clinical Research Project Manager
Posted on: January 15, 2022
Requisition ID: 51452 - Title: Clinical Research Project Manager
- Division: Arthrex, Inc. (US01) - Location: Naples, FL
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
Coordinates activities and deliverables with all study conduct
partners and is accountable for all project deliverables for each
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
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
Works to improve processes and solve routine problems of limited
scope and complexity following established policies and
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
Experience working for a medical device manufacturer,
pharmaceutical manufacture, or clinical research organization (CRO)
Direct orthopedic therapeutic area expertise is preferred.
Experience with multiple study types, including real-world evidence
(RWE), post-marketing, interventional, and observational is
Knowledge and Skill Requirements/Specialized Courses and/or
Strong knowledge of Good Clinical Practice/ICH guidelines and
applicable regulatory and ethical requirements.
Strong organizational skills and ability to manage time and work
Ability to embrace new technologies.
Excellent communication, presentation, interpersonal skills, both
written and spoken.
Strong technology skills in project management and clinical trial
Ability to effectively communicate project planning requirements to
all stakeholders, including task assignments, duration, and
Strong strategic thinker, excellent collaboration, and careful
attention to detail.
Awareness of orthopedic surgery principles, theories, and products
Strong accountability to project deliverable timing and budgets
Continuously seeking ways to improve complex systems of people and
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.
Keywords: Arthrex, Cape Coral , Clinical Research Project Manager, Executive , Naples, Florida
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