Clinical Project Manager

Globus Medical•Audubon, PA

About The Position

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary : The Clinical Project Manager will be responsible for supporting the development of single- and multicenter clinical investigation protocols, establishing study sites, training site staff, and performing data management and publication duties across multiple studies. The Clinical Project Manager will serve as the sponsor-side monitor, managing multiple aspects of the investigations on various products and technologies. The Clinical Project Manager will support in the creation and oversight of study documentation, records, scientific submissions, and conference materials. The Clinical Project Manager is accountable for the overall project scope, timelines, and budget to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate standards. Essential Functions : Serves as the primary point of contact, with oversight from leadership, for assigned studies, working with Product Development, Sales, Marketing, Regulatory Affairs, and Legal to communicate relevant updates accordingly through the life and closure of the study. Fosters relationships with physicians, sales representatives, and clinical teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection for the assigned study. Supports the design and review of all study documents for the assigned study, including the clinical study protocol, case report forms and subject questionnaires, informed consent form, electronic data capture (EDC) system, and other study tools. Supports the sponsor study start-up process by, including but not limited to, contributing to the conduct of the study kick-off meeting, negotiation and execution of agreements/budgets, and ensuring all qualification documents are executed and obtained. With oversight from leadership, supports the management of project budgets, communicates deviations from budget projections, and proposes solutions for budget deviations. Ensures timely processing of site payments for assigned study. Ensures site compliance with applicable regulatory requirements. Provides support to clinical investigators and site coordinators to resolve site-related issues. Ensures timely completion of patient enrollment and data collection in accordance with protocol requirements. Conducts remote and on-site monitoring including site qualification visits, site initiation visits, interim monitoring visits, and closeout visits, in compliance with standard operating procedures and expectations set by the governing regulatory authority. Supports the preparation, analysis, and review of clinical study data using basic comparative statistical techniques to support data interpretation and reporting. Supports generation of reports, conference abstracts, and journal publications in collaboration with leadership and investigators. Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures 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 the role. Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Requirements

Bachelor’s Degree with 2+ 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
Experience with Microsoft Office applications, SPSS or other statistical software
Working knowledge of FDA and EU MDR requirements (ISO14155) for clinical trial conduct
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

Nice To Haves

Previous publication history or contributions to peer-reviewed articles preferred

Responsibilities

Serves as the primary point of contact, with oversight from leadership, for assigned studies, working with Product Development, Sales, Marketing, Regulatory Affairs, and Legal to communicate relevant updates accordingly through the life and closure of the study.
Fosters relationships with physicians, sales representatives, and clinical teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection for the assigned study.
Supports the design and review of all study documents for the assigned study, including the clinical study protocol, case report forms and subject questionnaires, informed consent form, electronic data capture (EDC) system, and other study tools.
Supports the sponsor study start-up process by, including but not limited to, contributing to the conduct of the study kick-off meeting, negotiation and execution of agreements/budgets, and ensuring all qualification documents are executed and obtained.
With oversight from leadership, supports the management of project budgets, communicates deviations from budget projections, and proposes solutions for budget deviations.
Ensures timely processing of site payments for assigned study.
Ensures site compliance with applicable regulatory requirements.
Provides support to clinical investigators and site coordinators to resolve site-related issues.
Ensures timely completion of patient enrollment and data collection in accordance with protocol requirements.
Conducts remote and on-site monitoring including site qualification visits, site initiation visits, interim monitoring visits, and closeout visits, in compliance with standard operating procedures and expectations set by the governing regulatory authority.
Supports the preparation, analysis, and review of clinical study data using basic comparative statistical techniques to support data interpretation and reporting.
Supports generation of reports, conference abstracts, and journal publications in collaboration with leadership and investigators.
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
Ensures 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 the role.
Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.