Sr. Clinical Research Manager – Remote

Shockwave Medical
Published
November 3, 2022
Location
Santa Clara, California
Category
Other  
Job Type
Work Setting
Remote / Home-based

Description

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Description

Position Overview

The Sr. Clinical Research Manager will be responsible for the oversight of multiple clinical programs in vascular and/or structural heart therapies. The individual will be accountable for multiple clinical studies, including clinical study strategy, project management activities, oversight of multiple vendors, direct management of clinical personnel, and for conducting domestic and global clinical studies in compliance with regulatory standards and in alignment with Shockwave Medical Inc.’s (SWMI) business needs. This work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and is critical to the success of the business.

Essential Job Functions

  • Responsible for the day-to-day management of domestic and global clinical studies for pre- and post-market products.  Responsible for organizing, communicating, and evaluating team objectives for clinical studies.
  • Responsibilities include the development of clinical trial documentation, including clinical trial protocol development, case report form (CRF) development, and IRB or ethics submissions.
  • Develop site-training tools, interpret clinical data, manage investigational sites, and develop tracking tools and other clinical activities.
  • Managed clinical study teams, including clinical research managers and associates, focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies.
  • Manage all clinical trial vendors (e.g., CRO, imaging core lab(s), IVRS, central labs, IRB).
  • Responsible for the selection of CRO study staff and coordinating training, including documentation.
  • Oversee work and performance of clinical team members, including coaching and supporting any direct reports.
  • Represent Clinical Affairs at the product development core team.
  • Manage project timelines and vendor performance to meet departmental and corporate goals.
  • Oversee clinical study strategy with physician and statistical input.
  • Manage study budget and payment process for all clinical trial vendors and study sites.
  • Lead, prepared, and reviewed the project and study-related documents, including informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections of the Investigational Device Exemption (IDE) application.
  • Coordinate and manage investigational products, including accountability and reconciliation
  • Lead the review of clinical data, including data tables and listings.
  • Oversee clinical data and adverse events during the study. Working knowledge of safety boards, including CEC and DSMB.
  • Manage the training of investigators, site staff, and SWMI clinical staff.
  • Develop and revise annual, interim, and final clinical study reports, and clinical sections of pre- or post-market approval submissions.
  • Develop, review, and author Clinical Evaluation documentation as per MDR requirements, including clinical evaluation plan, literature search protocol, literature search report, clinical evaluation report
  • Oversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective action plans.
  • Other duties as assigned.

Requirements

  • Minimum Bachelor’s Degree in a scientific field of study
  • Thorough knowledge of Good Clinical Practice (GCP) is required.
  • Minimum 12 years experience directly supporting clinical research or relevant experience in medical/scientific area. 5+ years in a clinical management role, managing direct reports, trials, and projects.
  • Knowledge and experience in supporting device pre-and/or post-market clinical studies are required, including experience running investigational device exemption (IDE) trials.
  • Ability to travel 10-20% domestically and internationally.
  • Ability to work in a fast-paced environment while managing multiple priorities
  • Operate as a team and/or independently while demonstrating flexibility to changing requirements.
  • Experience with electronic data capture (EDC) systems.
  • A basic understanding of peripheral and coronary artery disease and structural heart therapies is an advantage.
  • Must have excellent verbal and written communication skills.
  • High attention to detail and accuracy.
  • Able to manage multiple project teams.
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