Senior Clinical Project Leader - Remote

INSIGHTEC Ltd.; Miami, Dallas (FL, TX); Hybrid; USD 110,000 - 165,000; Full time

Job summary

INSIGHTEC Ltd. is seeking an experienced SR Clinical Project Manager to lead global clinical trial teams, from start-up to closeout, in a remote US-based role. The position requires expertise in GCP, FDA regulations, and regulatory submissions, with strong communication and vendor management skills.

Responsibilities include developing study plans, coordinating with R&D, Regulatory, QA, and external vendors, and ensuring data integrity and safety oversight in a fast-paced, global environment.

Qualifications

• Bachelor’s degree in Life Sciences; advanced degree preferred.
• Excellent professional English writing for regulatory documents.
• Experience drafting clinical study protocols and regulatory submissions (PMA/510(k)).
• Strong communication and leadership across cross-functional teams.
• Knowledge of GCP, FDA regulations, ISO 14155, and global device regulations.

Responsibilities

• Lead the clinical trial study team and manage global activities from start-up to closeout.
• Ensure protocol compliance with GCP and local regulations; ensure data quality and audit readiness.
• Collaborate with R&D, Regulatory, Quality, Marketing for regulatory strategy and actions.
• Oversee IRBs/ECs and external vendors (CROs, biostatisticians, core labs).
• Develop PM plans, timelines, budgets; manage safety oversight and data management processes.

Skills

Clinical PM

GCP/FDA knowledge

Regulatory submissions

Vendor management

Biostatistics

Education

Bachelor's in Life Sciences

Tools

CSRs drafting tools

Job description

INSIGHTEC Ltd. is seeking an experienced SR Clinical Project Manager to lead global clinical trial teams, from start-up to closeout, in a remote US-based role. The position requires expertise in GCP, FDA regulations, and regulatory submissions, with strong communication and vendor management skills.

Responsibilities include developing study plans, coordinating with R&D, Regulatory, QA, and external vendors, and ensuring data integrity and safety oversight in a fast-paced, global environment.