Branch Medical Group · 2 hours ago
Clinical Project Manager
Audubon, PA
Full-time
Hybrid
Entry, Mid Level
2+ years expGlobus Medical is dedicated to improving the quality of life for patients with musculoskeletal disorders, and they are seeking a Clinical Project Manager to oversee clinical investigations. This role involves managing study protocols, training site staff, and ensuring compliance with regulatory standards while maintaining project timelines and budgets.
Health CareManufacturingMedicalMedical Device
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
Qualification
Required
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
Preferred
Previous publication history or contributions to peer-reviewed articles
Company
Branch Medical Group
Branch Medical Group is manufactures medical implants and graphic cases.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2015-02-25Acquired
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