Manager, Clinical Study Start-Up

Penumbra

2d•$135,000 - $187,000•Onsite

About The Position

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 Clinical Study Management and Legal teams, and provides strategic and tactical leadership for Penumbra-sponsored clinical studies. The position is also responsible for hiring, coaching, mentoring, resource planning, and anticipating future staffing needs. The manager leads execution of study and site start-up, amendment submissions and approvals, activation, and final site closure. The role oversees development of start-up materials and other study documents, preparation and negotiation of site trial budgets, and timely registration, maintenance, results reporting, and closure of studies in publicly accessible registries in accordance with applicable requirements. The manager reports start-up progress, communicates delays and proposed actions, and establishes and monitors performance and quality metrics. The position provides guidance on IRB and Ethics Committee submissions and review responses, leads continuous improvement of clinical processes and systems, and drives development and implementation of SOPs and work instructions. It directly supervises ICRA and CBA staff, allocates resources across studies, manages timelines, identifies and escalates issues, and acts as a liaison across functions. The role requires adherence to the company Quality Management System and applicable domestic and global regulations, standards, and procedures. The work is performed in a general office environment, with willingness and ability to work onsite. Business travel may be 0%–10%. The position may involve potential exposure to blood-borne pathogens and requires some lifting and moving of up to 15 pounds, movement between buildings and floors, and extended periods using a computer or standard office equipment. The posted salary range is $135,000–$187,000 for a mid-cost labor market; pay may vary by region and individual qualifications, skills, competencies, and work location.

Requirements

Bachelor's degree in Biology, Nursing, Biomedical or Physical Sciences, or a related field, with 7 or more years of experience in preclinical research or the medical device/pharmaceutical industry, or an equivalent combination of education and experience.
At least 3 years of experience in operational management of clinical studies from start-up to close-out, vendor management, and planning cross-functional operational activities.
Knowledge of ICH-GCPs, 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.

Nice To Haves

Medical device experience.
Strong oral, written, and interpersonal communication skills.
Excellent organizational skills and ability to prioritize assignments while handling multiple projects simultaneously.
Strong computational skills and proficiency with Microsoft Office, including Word, Excel, OneNote, and PowerPoint.
Ability to apply strong analytical, business, communication, and technical skills, including standards, principles, theories, concepts, and techniques.

Responsibilities

Lead the team supporting study and site start-up execution, amendment submissions and approvals, activation processes, and final site closure activities.
Lead or supervise the development of study start-up materials and other study documents, including consent templates, questionnaire licensing, and study manuals.
Lead and oversee preparation and negotiation of initial clinical trial budgets and budget amendments with clinical study sites across multiple studies.
Oversee and support timely registration, maintenance, results reporting, and closure of clinical studies in publicly accessible registries such as ClinicalTrials.gov, in accordance with applicable requirements.
Provide management with periodic updates on site start-up progress and strategic impact; communicate actual or potential delays and propose actions to support project timelines.
Establish, monitor, and report study start-up performance and quality metrics to identify trends, drive corrective actions, and support continuous improvement.
Provide oversight and guidance to clinical staff preparing and following up on IRB and Ethics Committee submissions, including coordinating responses to review comments and requests for additional information.
Lead continuous improvement initiatives for clinical processes, systems, tools, and procedures; drive review, development, and implementation of SOPs and work instructions; promote consistent compliance.
Recruit, hire, and directly supervise ICRA and CBA team members, including goal setting, development planning, training, coaching, performance feedback, and performance reviews.
Allocate resources across studies and manage project timelines to meet departmental and company goals.
Identify and escalate site- and study-related issues to management.
Serve as a key liaison between cross-functional teams and establish, communicate, and align goals and priorities for the ICRA and CBA teams.
Adhere to the Company's Quality Management System and applicable domestic and global quality system regulations, standards, and procedures.
Understand and follow applicable security, privacy, and compliance principles, regulations, standards, and procedures.
Ensure other department members follow the QMS, regulations, standards, and procedures.
Perform other work-related duties as assigned.

Benefits

Medical, dental, and vision insurance.
Life and AD&D insurance.
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, increasing with tenure.
Paid sick time in compliance with applicable laws.
Competitive compensation package and equity program, when applicable.
Collaborative teamwork environment with ongoing learning and performance rewards.