External Research Program Manager

Job Description:

With minimal supervision, the Senior Clinical Research Associate will assume project management responsibilities for assigned studies and will be responsible and accountable for the timely completion of deliverables.

Oversees, designs, plans and develops clinical evaluation research studies (protocol, informed consent, case report forms, training, etc.) in compliance with regulatory requirements, standard operating procedures (SOP), and alignment with study objectives.

• Conduct and report on Site Qualification (SQV), Site Initiation(SIV), Site Monitoring (SMV) and Close-Out (COV)onsite monitoring visits in accordance with study specific clinical data monitoring plans
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management including tracking of all site monitoring-related activities and action items
• Training site staff on study procedures, ensuring that staff are qualified to carry out delegated tasks
• Collect and review regulatory documentation, and ensure accuracy between site files and TMF
• Responsible for data management
• Manage preparation and execution of site initiation/ training activities and associated meetings
• Ensure all study materials, including Regulatory Binders, subject stipend cards and devices, are appropriately organized and available on site
• Prepare/coordinate documentation with site for IRB applications and renewals
• Coordinate meetings with physicians/ investigators and study site staff as needed
• Assisting with preparation of technical documentation for regulatory submissions, including IDE and PMA FDA submissions
• Communicate with internal project teams regarding study progress
• Participation in the development of company clinical SOPs and work instructions
• Participation in the development of study-related documents

Requirements:

• Bachelor's degree, ideally within Life Sciences or an equivalent combination of education, training & experience
• Minimum of 4 years of experience in Orthopedics clinical research project management within the medical device industry or advanced degree with a minimum of 3 years in clinical research program/project management within the medical device industry
• Must have experience in design of Orthopedic Trials
• Demonstrated ability to forge relationships with clinical sites and colleagues.
• Able to participate in several projects at once, maintaining a flexible working style and attention to detail
• Option to work remotely from home
• Willing to travel up to 70%
• Proficiency in MS Office applications

ABOUT DJO GLOBAL
DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. Our products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Our products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of our medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast, Chattanooga, CMF, Compex, DonJoy, ProCare, Exos, Dr. Comfort, DonJoy Performance and DJO Surgical.

For additional information on the Company, please visit www.DJOglobal.com.

DJO is a growing subsidiary of diversified technology leader Colfax Corporation

EOE AA M/F/VET/Disability

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.