Clinical Study Manager-Medical Device

Kelly Science, Engineering, Technology & Telecom; Plano (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom in Plano, TX seeks a Clinical Study Manager to lead planning, execution, and oversight of clinical studies across the medical device lifecycle, ensuring alignment with ISO 14155, FDA, EU MDR, and GCP. You will coordinate timelines, budgets, site performance, and vendor relationships to generate robust clinical evidence.

Ideal candidates have 3–8+ years of clinical research experience, with 2+ years in medical device study management, strong

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.
• Certification (ACRP, SOCRA) and 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

Project management

Communication

Organizational skills

Clinical research

Regulatory knowledge

GCP

Travel readiness

Education

Bachelor's degree in Life Sciences/Engineering

Master's or PhD preferred

Tools

EDC

CTMS

eTMF

Job description

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