Clinical Study Manager Medical Device

Kelly; Plano (TX); Hybrid; USD 134,000 - 145,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Telemedicine

Paid holidays

Transit benefits

Job summary

Kelly Science & Clinical is seeking a Clinical Study Manager in Plano, TX. This direct-hire role leads planning, execution, and oversight of clinical studies across the medical device lifecycle, ensuring compliance with ISO 14155, FDA, EU MDR, and GCP.

You will manage study timelines, budgets, vendor relationships, and data integrity while collaborating with Regulatory, Quality, Medical Affairs, and Product Development teams to generate robust clinical evidence.

Qualifications

• 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

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

Skills

Clinical Research

Project Management

Regulatory Knowledge

EDC/CTMS/eTMF

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Master’s or PhD preferred

Tools

EDC

CTMS

eTMF

Job description

Description

Clinical Study Manager

• Pay: $134,000-$145,000
• FT or PT: Full-Time
• Location: Plano, Texas (Hybrid)

Kelly Science & Clinical i 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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work‑related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short‑term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.