W.L. Gore
Clinical Study Manager - Phoenix, AZ - Phoenix, AZ

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Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries, including medical devices, fabrics, electronics, and manufacturing, for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.
Job Description
Gore Medical Products has provided creative therapeutic solutions to complex medical problems for 35 years, saving and improving the quality of lives worldwide. As a leading manufacturer of vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures, we are looking for a Clinical Study Manager to join our Stroke team in Phoenix, AZ. If you are searching for a company where you can make a difference, we're looking for you. In this role, you will plan, implement, and manage parts of and/or the overall conduct of clinical research projects. Your primary responsibility will be to coordinate activities of appropriate Gore associates, clinical site personnel (investigators, coordinators, etc.), and external personnel (e.g., contract research organizations) to ensure compliance with the protocol and overall clinical objectives. The ideal candidate will:
  • Be passionate about managing clinical studies for state-of-the art implantable medical devices
  • Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
  • Recognize the importance of building and maintaining strong interpersonal relationships
Additional responsibilities include:
  • Developing, approving, and distributing study-related documents and other study tools to clinical sites and review committees
  • Managing distribution, collection, and tracking of regulatory documentation for clinical-site personnel to ensure compliance at both the clinical sites and the sponsor central file
  • Participating in the site qualification, study initiation, and study-closure processes
  • Assisting with management of medical-device distribution, receipt, use, and return in accordance with applicable regulatory requirements
  • Reviewing case report forms (CRFs) for clinical content
  • Reviewing adverse events for safety and effectiveness information
  • Tracking and reporting progress of studies, including patient screening, enrollment, data collection, adverse-event documentation and reporting, and clinical portions of regulatory submissions
  • Assisting in the query-writing and resolution process, as required. Identifying and gathering missing or incomplete data from the investigational sites.
  • Conducting site visits, as necessary
  • Acting as a company liaison to work with clinical sites, contract research organizations (CROs), and other vendors to resolve site-related issues
  • Assisting the Clinical Affairs Leader with the development and implementation of corrective actions for addressing noncompliance issues at individual sites and across studies
  • Maintaining familiarity with current clinical literature and regulatory requirements
  • Participating in Clinical Affairs process improvement initiatives
  • Preparing and presenting protocol and general study information at sponsor and investigator meetings
JOB REQUIREMENTS:
Required Job Qualifications
  • Bachelor's degree in a science- or health-related field
  • A minimum of 2 years of experience in clinical or scientific research, nursing, or the medical device or pharmaceutical industries
  • Successful experience working on cross-functional teams
  • Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, Lotus Notes)
  • Strong organizational skills, flexibility, and ability to multitask
  • Strong verbal and written communication skills
  • Ability to travel up to 30%
Desirable Job Qualifications
  • Experience with endovascular medical devices
  • Investigational device exemption (IDE)/premarket approval (PMA) experience
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening EEO/AA Employer (applies to all positions located in the U.S.) Keywords: Gore, Phoenix, AZ, clinical study, clinical study manager, study manager, clinical project manager, project manager, clinical affairs, clinical research, medical device, implantable medical device, endovascular, stroke, IDE, PMA, healthcare, health care, regulatory, regulations, documentation, compliance, CRF

To apply for this position, please copy and paste the following link into your browser address bar:
http://wlgore.contacthr.com/26883859

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