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Manager, Clinical Study Start-Up

10 hours, 10 minutes ago
United States
Full-time
Lead
Operations Manager
Project and Program Management
Apply Now
Penumbra

Penumbra

Penumbra Inc is a global healthcare company focused on innovating novel technologies to address challenging medical conditions in neuro and peripheral vascular markets. They design, develop, manufacture, and market medical devices for interventional th...

Health Care Providers & Services
1001-5000
Founded 2004
View All Jobs 14

Description

  • Lead ICRA and CBA teams supporting study and site start-up, amendment submissions, site activation, and final site closure activities.
  • Oversee development of start-up materials and study documents, including consent templates, questionnaire licensing, and study manuals.
  • Lead preparation and negotiation of clinical trial budgets and budget amendments with study sites across multiple studies.
  • Oversee clinical study registration, maintenance, results reporting, and closure in public registries, including ClinicalTrials.gov.
  • Monitor site start-up progress, communicate risks or delays to management, and implement actions to protect project timelines.
  • Establish and report start-up performance and quality metrics, driving corrective actions and continuous improvement.
  • Guide clinical staff through IRB and Ethics Committee submissions and responses to review comments or information requests.
  • Lead improvements to clinical processes, systems, tools, SOPs, and work instructions while ensuring regulatory and QMS compliance.
  • Recruit, coach, develop, and evaluate ICRA and CBA team members; plan staffing and allocate resources across studies.
  • Act as the liaison with cross-functional teams, Clinical Study Management, Legal, and vendors to align priorities and resolve site- or study-related issues.

Requirements

  • Bachelor’s degree in Biology, Nursing, Biomedical or Physical Sciences, or a related field, plus 7+ years of relevant experience; an equivalent combination of education and experience may be considered.
  • 3+ years of experience managing operational aspects of clinical studies from start-up through close-out, vendor management, and cross-functional operational planning.
  • Knowledge of ICH-GCP, 21 CFR, and other applicable clinical research regulations and standards.
  • Experience creating and negotiating clinical trial budgets and contracts.
  • Extensive clinical research knowledge and understanding of clinical trial methodology across functions.
  • Medical device industry experience (preferred).
  • Strong oral, written, interpersonal, analytical, business, and organizational skills, including the ability to manage multiple priorities.
  • Proficiency with Microsoft Office, including Word, Excel, OneNote, and PowerPoint.
  • Willingness and ability to work on site and travel up to 10% for business.
  • Ability to meet office-based physical requirements, including computer work, moving between buildings/floors, and lifting up to 15 pounds.

Benefits

  • Salary range of $135,000–$187,000 for a mid-cost labor market, with location-based adjustments.
  • Competitive total compensation package and equity program, when applicable.
  • Medical, dental, vision, life, AD&D, short- and long-term disability insurance for eligible employees.
  • 401(k) with employer match.
  • Paid parental leave.
  • Eleven paid company holidays annually, at least 15 accrued vacation days that increase with tenure, and paid sick time.

Interested in this position?

Apply directly on the company website

Apply Now

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