Clinical Study Manager, Medical Devices – Lead & Impact

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, 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