Manager, Clinical Study Start-Up

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.