Clinical Research Project Manager
At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.
Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!
The Clinical Research Project Manager will develop clinical trial protocols, establish trial sites, train site staff, and perform data management and publication duties across multiple studies. The Clinical Research Project Manager will act as the sponsor-side monitor, and manage multiple aspects of the trial, and concurrent trials on various orthopedic implant and robotics technologies. You will conduct retrospective site visits for data gathering, prospective site initiation visits with site monitoring, generate and distribute internal and external communications/publications, and liaise with interested parties regarding outcome reports for marketing, reimbursement, and regulatory affairs. You will play a leading role in generating and overseeing documentation and records, and management of scientific submissions and conference materials.
The responsibilities of the position include, but are not limited to, the following:
- Conduct and complete multiple high-quality clinical studies in a timely manner for product support
- Work with Product Development, Sales & Marketing, Regulatory Affairs, and Reimbursement to identify clinical research needs for each project
- Coordinate with product development to identify sites and surgeons for clinical research and publications
- Conduct site evaluations and make recommendations to Group Manager, Director, and other Globus management as appropriate
- Ensure proper site initiation and IRB documentation during trial
- Provide support to clinical investigators and site coordinators to resolve site-related issues
- Ensure timely completion of patient enrollment & provide OR support for study sites as necessary
- Support data entry through electronic data capture
- Prepare, analyze, and review data for statistical analysis including basic comparative statistical tools
- Generate reports, conference abstracts, journal publications in collaboration with management and surgeon principle investigators
- Multitask 10-15 projects at various stages of completion
- Ideal candidate will have previous clinical experience as a CRA or Clinical Project Manager with demonstrated abilities beyond management, including interpretation of radiographic measurements, health status grading scales, and patient-reported outcomes.
- Write and submit quality clinical articles for publication in spine and orthopedic journals
- Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
In order to be qualified for this role, you must possess the following:
- Bachelor’s Degree with 3+ years’ clinical experience in the Sciences / Engineering / Health Care / Management OR surrogate experience in Medical Device Clinical Affairs, Product Development, Marketing, and Management in a fast-paced environment
- Master’s Degree (or higher) with equivalent experience in the Sciences / Engineering / Health Care / Management and idealize skillsets (mentioned above) are preferred with job scaling based on experience
- Experience with Windows, Microsoft Office, E-mail, and Microsoft Project, SPSS or other statistical software
- Demonstrated ability and experience with clinical investigators to motivate, lead, and provide support to group towards rapid, compliant enrollment
- Excellent oral and written communication skills
- Ability to travel up to 10-30% of the time
- Writing Sample will be Required
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.