Clinical Project Lead for Medical Devices & Trials

Biolinq, Inc.; San Diego (CA); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

HSA and FSA

Holidays

Job summary

Biolinq, Inc. in San Diego is seeking a Clinical Project Manager to lead multi-site clinical studies, ensuring protocol adherence and compliance with applicable regulatory requirements.

You will partner with Quality, Regulatory, Engineering, and Marketing to align study timelines with product development milestones, manage budgets, CTAs, TMF, and vendor contracts in a fast-paced early-stage medical device environment. Travel up to 50% is required.

Qualifications

• Bachelor's or higher STEM degree with 5+ years clinical study experience.
• Extensive knowledge with CTMS, eTMF, EDC and FDA submission processes.
• Independent, highly organized and collaborative.

Responsibilities

• Create and manage project plans and timelines for clinical studies.
• Develop SOPs and quality system documentation.
• Track budgets, PO and vendor invoices; escalate variances.
• Support CTAs, NDAs, and vendor contracts; TMF oversight.

Skills

Clinical trial mgmt

Leadership

CTMS

EDC

FDA submissions

Education

BA/BS in STEM

Tools

CTMS

eTMF

EDC

Job description

Biolinq, Inc. in San Diego is seeking a Clinical Project Manager to lead multi-site clinical studies, ensuring protocol adherence and compliance with applicable regulatory requirements.

You will partner with Quality, Regulatory, Engineering, and Marketing to align study timelines with product development milestones, manage budgets, CTAs, TMF, and vendor contracts in a fast-paced early-stage medical device environment. Travel up to 50% is required.