Business Segment: Healthcare Technology & Medical Innovation
Location(s): United States; Wisconsin; Waukesha
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: The Clinical Affairs Project Manager (CAPM) is responsible for one or more clinical/research (single or multi-center) studies/projects. As the team leader, lead the overall direction, communicate clear expectations and deliverables for the successful management and completion of Clinical/Research programs. Partner with peers and leaders of business, academic institutions, and GE Global Research to meet mutual objectives for the business and academic research collaborators.
Essential Responsibilities: • Lead a cross-functional team, facilitating the team’s abilities to fulfill their responsibilities in all aspects of clinical /research studies and in compliance with applicable Medical Device regulations, GCP (Good Clinical Practice,) the HAT (Human and Animal Trial procedure), Work Instructions, Corporate Policies, Guidelines and internal Standards. • Manage operational aspects of the team's assigned projects including third-party vendor activities. • Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for team's assigned projects. • Responsible for the timely and accurate completion of team's project documentation, such as protocols, amendments, case report forms and study report, stored appropriately and audit-ready. • Interfaces with Regulatory Agencies as required. • Ensures overall clinical/regulatory compliance of investigational sites with applicable regulations. • Actively involved in Corrective and/or Preventive actions (CAPA) tied to Clinical/Research process. • Educate GEHC research teams on Good Clinical Practice guidelines, HAT Procedure and applicable laws and regulations as they apply to research study. • Establish close working relationships with the technology, medical, clinical, quality, regulatory, legal, and marketing organizations within the assigned modality(s) to execute the roadmap associated with the research priorities. • Lead research in concert with external investigators and GEHC Clinical Affairs in areas strategically important to the modality, including technology development, disease states and patient unmet clinical needs. • Lead work with product team to establish long-term research roadmap, defining study requirements, and approving proposals and justifications • For GE-Sponsored studies, assist with development of protocols, training plans, informed consent forms, and other research documents/forms/logs, as required • Participate in the conduct of medical and clinical advisory boards • Provide scientific and clinical support to researchers and GE colleagues as needed
Qualifications/Requirements: • Bachelors in Clinical Research, Physics, Biology, Engineering or related clinical field (R.N. RT…) • Experience working in a clinical research role OR a minimum of 3 years program/program management experience • Excellent communication & interpersonal skills • Ability to speak and read English • Ability to influence locally and globally to ensure studies are performed appropriately • Experience in medical technology & applications • Ability to manage research budgets and resources to ensure timelines are met • Experience in working directly with academic researchers • Ability and willingness to travel globally up to 20% • GCP (Good Clinical Practice) training OR the ability to complete appropriate GCP training within 60 days of hire • Comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position • Identify and report any quality or compliance concerns and take immediate corrective action as required
Desired Characteristics: • MBA, PhD or related advanced degree in medical sciences including MD • Previous medical device research experience • Previous clinical trials experience • Experience with IRBs or Ethics Committees and regulatory agencies • Good working knowledge of Code of Federal Regulation (CFR) and ISO requirements • Previous experience with Siebel CTMS • Previous experience working for a Contract Research Organization • Publication history • Knowledge of QMS
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