Hybrid Clinical Study Lead – Medical Devices

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

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.