Clinical Study Manager-Medical Device

Kelly Services; Texas; Hybrid; USD 134,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Telemedicine

Transit spending account

Paid holidays

Job summary

Kelly Science & Clinical is seeking a Clinical Study Manager for a direct-hire position at our innovative medical device client. This role is based in Plano, Texas (Hybrid) and leads clinical investigations across the product lifecycle, ensuring compliance with ISO 14155, FDA regulations, EU MDR, and GCP.

You will collaborate with Regulatory Affairs, Quality, Medical Affairs, and Product Development to generate robust clinical evidence.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field (Master’s/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.
• Certification (ACRP, SOCRA) and interventional studies experience preferred.
• Ability to travel up to 40% to clinical sites and meetings.

Responsibilities

• Lead study start-up to closeout (IDE, post-market, PMCF, registries, observational studies).
• Develop and manage project plans, timelines, milestones, and budgets.
• Oversee study documentation including protocols, informed consent forms, CRFs, statistical plans, and agreements.
• Manage site selection, qualification, initiation, monitoring, and performance oversight.
• Ensure regulatory and GCP compliance, supporting audits and inspections.
• Supervise CROs and labs; monitor resources and expenditures.
• Guide Clinical Research Associates and study team with operational leadership.
• Drive risk management and data quality improvements.

Skills

Project management

Clinical research

Regulatory compliance

Communication skills

Vendor management

Education

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

Master’s or PhD preferred

Tools

EDC

CTMS

eTMF

Job description

Job Description

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

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.

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 opportuni