General Summary
The Manager of Clinical Study Start-Up leads the in-house Clinical Research Associate (ICRA) and Clinical Budget Analyst (CBA) teams and oversees study and site start-up activities, including regulatory documentation, site support tools, clinical site budgets, vendor management, and site activation. The role establishes and applies start-up best practices, represents Clinical Operations on cross-functional project teams, partners with our Clinical Study Management and Legal teams, and provides strategic and tactical leadership for Penumbra-sponsored clinical studies. This position is also responsible for hiring, coaching, mentoring, resource planning, and anticipating future staffing needs.
Specific Duties and Responsibilities
• Lead a team that supports study and site start-up execution, amendment submissions and approvals, activation process, and final site closure activities. *
• Lead or supervise development of study start-up materials, and other study documents, e.g., consent templates, questionnaire licensing, study manuals. *
• Lead and oversee the preparation and negotiation of initial clinical trial budgets and budget amendments with clinical study sites across multiple clinical studies. *
• Oversee and support the timely registration, maintenance, results reporting, and closure of clinical studies in publicly accessible registries, such as ClinicalTrials.gov, in accordance with applicable requirements. *
• Provide periodic updates to management regarding site start-up progress related to their strategic impact. Communicate potential or actual delays and propose actions to ensure that project timelines are met. *
• Establish, monitor, and report study start-up performance and quality metrics to identify trends, drive timely corrective actions, and support continuous improvement across clinical studies. *
• Provide oversight and guidance to clinical staff in the preparation and follow-up of Institutional Review Board (IRB) and Ethics Committee (EC) submissions, including the development and coordination of responses to review comments and request additional information. *
• Leads continuous improvement initiatives for clinical processes, systems, tools, and procedures; drives the review, development, and implementation of SOPs and work instructions; and promotes consistent compliance with applicable requirements across clinical studies. *
• Recruits, hires, and directly supervises ICRA and CBA team members, including goal setting, development planning, training, coaching, ongoing performance feedback, and performance reviews. *
• Allocates resources across studies and manages project timelines to meet departmental and company goals.*
• Identifies and escalates site- and study-related issues to management. *
• Serves as the key liaison between cross-functional teams and establishes, communicates, and aligns goals and priorities for the ICRA and CBA teams. *
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understands relevant security, privacy and compliance principles and adheres 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.
*Indicates an essential function of the role
Required Qualifications
Minimum education and experience:
• Bachelor's degree in Biology, Nursing, Biomedical or Physical Sciences or related field with 7+ years of experience in preclinical research, or medical devices/pharmaceutical industry, or an equivalent combination of education and experience.
• 3+ years’ experience in the operational aspects of managing clinical studies from start-up to close-out, vendor management, and planning cross-functional operational activities required.
• Knowledge of ICH-GCPs and 21 CFR, and other relevant regulations and standards.
• Experience creating and negotiating clinical budgets and contracts.
• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
Preferred Qualifications:
• Medical device experience desirable
• Strong oral, written, and interpersonal communication skills
• Excellent organizational skills, with ability to prioritize assignments while handling various projects simultaneously
• Strong computational skills; proficiency with Microsoft Office (Word, Excel, OneNote, and PowerPoint)
• Ability to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts, and techniques.
Working Conditions
• General office environment
• Willingness and ability to work on site.
• May have business travel from 0% - 10%
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 15 pounds
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels daily.
Salary Range: $135,000 – $187,000
This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
• 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, 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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.