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Clinical Study Manager-Medical Device
Plano, TX, US
Scientific
Bachelors Degree
Full Time, Direct Hire
$134,000-
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Plano, TX, US
$134,000-
Experienced (Non-Manager)
Full Time, Direct Hire
Medical Devices and Supplies
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Title: Clinical Study Manager
Pay: $134,000-$145,000
FT or PT: Full-Time
Location: Plano, Texas (Hybrid)
Kelly® Science & Clinical is seeking a Clinical Study Manager for a direct-hire position at our innovative medical device client. If you’re passionate about leading clinical investigations for novel medical technologies and ready to take the next step in your career, trust The Experts at Hiring Experts.
As the Clinical Study Manager, you will lead the planning, execution, and oversight of clinical studies spanning the full medical device product lifecycle, including premarket and postmarket initiatives. This high-impact role ensures studies are conducted in alignment with ISO 14155, FDA regulations, EU MDR, and Good Clinical Practice (GCP). You will serve as the primary operational lead for assigned research projects, managing study timelines, budgets, site performance, vendor relationships, and data integrity. You’ll collaborate cross-functionally with Regulatory Affairs, Quality, Medical Affairs, and Product Development teams to support robust clinical evidence generation.
Key Responsibilities:
- Lead and coordinate all aspects of clinical research, from study start-up to closeout (IDE, post-market, PMCF, registries, and observational studies)
- Develop and manage project plans, study timelines, milestones, and budgets
- Oversee clinical study documentation including protocols, informed consent forms, CRFs, statistical plans, and agreements
- Manage site selection, qualification, initiation, monitoring, and performance oversight
- Ensure compliance with regulatory and GCP requirements, supporting audits and inspections
- Supervise vendors (CROs, labs) and monitor resource allocation and expenditures
- Guide Clinical Research Associates and study team members with operational leadership
- Drive risk management, data quality, and continuous process improvement
Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or related field; Master’s or PhD preferred
- 3–8+ years of clinical research experience, including 2+ years in medical device study management
- Strong knowledge of ISO 14155, FDA regulations, EU MDR, and GCP
- Experience with EDC, CTMS, and eTMF systems
- Exceptional project management, organizational, and communication skills
- Certification (ACRP, SOCRA) and experience with interventional/procedural studies (IR, vascular, cardiology) preferred
- Ability to travel up to 40% to clinical sites and industry meetings
Ready to make an impact in medical device innovation? Apply today!
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Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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