Field Clinical Solutions Specialist

TISSIUM; Boston, Northern (MA, KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Tissium is seeking a Field Clinical Product Specialist to lead site management and monitoring for multiple clinical studies in the U.S. The role requires extensive field visits, strong regulatory knowledge (ICH-GCP/FDA), and collaboration with investigators to ensure high-quality data and patient safety.

Ideal candidates have 8+ years in clinical operations or medical devices, plus experience with field-based support, training, and TMF management.

Qualifications

• Undergraduate degree in Life Science, Nursing, Medicine, Biomedical Engineering required.
• Clinical Research Certification is an asset.
• RN certification is an asset.
• Minimum 8+ years of related job experience.
• Minimum 5+ years of experience with medical devices.
• Minimum 5+ years of field monitoring and site management.
• Demonstrated knowledge of ICH-GCP and FDA regulations.
• Experience working with patients in clinical settings.

Responsibilities

• Responsible for site management and monitoring of assigned clinical study(ies).
• Maintain relationships with Investigators, Study Coordinators and site staff to meet recruitment targets and deliver data on time.
• Report adverse events and product quality issues within required timelines.
• Maintain trial management systems and TMF documentation.
• Perform field monitoring visits including qualification, initiation, interim and closeout visits.
• Complete monitoring reports and correspondence in line with SOPs.

Skills

Clinical research

Field monitoring

Site management

Interpersonal skills

Travel readiness

Education

Undergraduate degree in Life Science, Nursing, Medicine, Biomedical Engineering

Tools

MS Office

CTMS

eTMF

IRT

Job description

Tissium is seeking a Field Clinical Product Specialist to lead site management and monitoring for multiple clinical studies in the U.S. The role requires extensive field visits, strong regulatory knowledge (ICH-GCP/FDA), and collaboration with investigators to ensure high-quality data and patient safety.

Ideal candidates have 8+ years in clinical operations or medical devices, plus experience with field-based support, training, and TMF management.