Clinical Field Manager

Summary

Join Penumbra as a Clinical Field Manager and lead a field support team, collaborating with Clinical Project Managers on clinical trials. You will supervise and develop Clinical Research Associates, contribute to process improvements, and oversee monitoring reports. This remote US-based role requires experience in clinical research within the pharmaceutical or biotechnology industry, including managing phase 1-3 studies. A Bachelor's degree in a related field and 8+ years of experience are required. Penumbra offers a competitive compensation package including benefits such as medical, dental, vision, life insurance, 401k, paid parental leave, and paid time off.

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
• Extensive people management and project management skills required
• 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
• Must be eligible to work in the United States without restriction

Responsibilities

• 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

Preferred Qualifications

• 1-3+ years of experience in a supervisory role
• ISO 14155 and MDR 2017/745 knowledge

Benefits

• 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
• Paid sick time in compliance with applicable law(s)
• 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