MedTech Clinical Study Manager (Hybrid, Plano)

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

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.