Clinical Field Manager

April 2

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Penumbra, Inc.

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Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.

1001 - 5000 employees

Founded 2004

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

•The Clinical Field Manager manages the field support team and works alongside the Clinical Project Managers to support the respective clinical trials. May manage CROs or external vendors. •Develops and applies best practices in the development, initiation, planning, execution, control and closing of projects. •Actively participates in cross functional project teams representing clinical operations from both a strategic and tactical perspective. •The Clinical Field Manager will be based in their remote US home office. •Unfortunately, sponsorship is not available for this opportunity, so you must be eligible to work in the United States without restriction. •Supervise, train, coach, develop, and evaluate Clinical Research Associates. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. •Collaborate with Clinical Project Managers on development of study start up materials, informed consent templates, and study manuals. •Contribute to the improvement of processes, systems, tools, and procedures. May contribute to SOP/WI review and development. Ensures compliance across studies. •Troubleshoot with team members on site compliance and improvement plans. •Oversee completion and review of monitoring reports, ensuring accuracy and timely reporting for team members. •Attend monitoring visits with team members as needed to ensure consistency in the field. •Oversee investigative sites' adherence to regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and Clinical Research Organization (CRO) team members. •Review clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory documents (i.e. IND annual reports, annual or periodic safety reports, IND and NDA filings) for accuracy, consistency and quality. •Participate in assessment and selection of Contract Research Organizations (CROs), sites, and other vendors. May perform qualification visits as needed, solicit and review proposals, review or negotiate budget and Scope of Work. •Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. •Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. •Ensure other members of the department follow the QMS, regulations, standards, and procedures. •Perform other work-related duties as assigned.

🎯 Requirements

•Bachelor’s degree in Biological sciences or a health-related field (e.g., Biology, Chemistry, Biochemistry, Nursing, Biomedical or Veterinary Sciences) preferred with 8+ years of experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required, or an equivalent combination of education experience •Clinical research experience in the pharmaceutical or biotechnology industry required; medical device experience preferred •Experience in the operational aspects of managing phase 1-3 clinical studies from start-up to closeout, vendor management, and planning cross-functional operational activities •Knowledge of ICH-GCPs and 21 CFR is required, along with extensive clinical research knowledge and cross-functional understanding of clinical trial methodology. ISO 14155 and MDR 2017/745 knowledge is preferred •Extensive people management and project management skills required •1-3+ years of experience in a supervisory role preferred •High degree of accuracy and attention to detail •Strong oral, written, and interpersonal communication skills •Proficiency with MS Word, Excel, and PowerPoint •Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

🏖️ Benefits

•A collaborative teamwork environment where learning is constant, and performance is rewarded. •The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. •A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).