Clinical Trials Program Lead – Medical Devices

Biolinq; 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

PTO

Job summary

Biolinq, a venture-backed digital health company, is developing a novel intradermal biosensor platform and the software data extraction SDK. The Clinical Project Manager will oversee clinical studies, ensuring protocol compliance and regulatory adherence while working with sites, CROs, IRBs, and vendors.

The role focuses on planning, execution, and oversight across multiple studies in a lean, early-stage environment, with potential travel and a non-remote work setup at Biolinq HQ.

Qualifications

• Bachelor’s degree in STEM with 5+ years of related experience or equivalent.
• Degree in Biology/Health Sciences or related field desirable.
• Extensive knowledge with CTMS, eTMF, EDC, Monitoring & Operational Plans and FDA submission processes.

Responsibilities

• Create and manage project plans and timelines for Clinical Department projects.
• Develop and improve SOPs, work instructions, and quality system documentation.
• Track budgets, PO's, and vendor invoices; escalate variances to leadership.

Skills

Clinical trial leadership

Independent/self-motivated

Highly organized

Multitasking

Regulatory knowledge

Education

Bachelor’s degree in STEM

Advanced degree desirable

Tools

CTMS

eTMF

EDC

FDA submissions (IDE/PMAs/510(k))

Job description

Biolinq, a venture-backed digital health company, is developing a novel intradermal biosensor platform and the software data extraction SDK. The Clinical Project Manager will oversee clinical studies, ensuring protocol compliance and regulatory adherence while working with sites, CROs, IRBs, and vendors.

The role focuses on planning, execution, and oversight across multiple studies in a lean, early-stage environment, with potential travel and a non-remote work setup at Biolinq HQ.