Clinical Trials Program Manager - Medical Devices

Biolinq Incorporated; 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)

Paid time off

Job summary

Biolinq Incorporated in San Diego, CA is seeking an experienced Clinical Research/Project Manager to drive clinical studies for a wearable biosensor platform. You will partner with sites, CROs, and internal teams to ensure protocol adherence, regulatory compliance, and on-time delivery across multiple studies.

Candidates bring 5+ years in clinical trial management, a STEM degree, and hands-on experience with CTMS, EDC, and TMF.

Qualifications

• Bachelor’s degree in a STEM field with 5+ years experience in clinical trials.
• Experience leading cross-functional teams and sites.
• Strong knowledge of CTMS, eTMF and EDC systems.
• Familiarity with FDA submission processes (IDE/PMA/510(k)).

Responsibilities

• Create and manage project plans and timelines for Clinical Department projects.
• Develop and improve SOPs and QA documentation as the organization scales.
• Track budgets, PO"s, and vendor invoices; escalate variances.
• Negotiate and execute CTAs, NDA s, and CRO contracts.
• Maintain TMF readiness for inspections across studies.
• Manage study requests from inception to Clinical Readiness Review.
• Develop study materials and training resources.
• Oversee site and vendor qualification and day-to-day work.
• Assist with device supply planning for site enrollment.
• Train site staff on Clinical and Commercial devices per IFU.
• Ensure risk-based monitoring and document protocol deviations.
• Collaborate with Quality, Regulatory, Engineering, and Marketing to align timelines.
• Support regulatory submissions for US and international studies.
• Participate in regulatory audits and troubleshooting.
• Perform other duties as assigned.

Skills

Clinical trial leadership

Independent, self-motivated

Highly organized

Multi-tasking

Cross-functional collaboration

Education

Bachelor’s degree in Biology or related field

Tools

CTMS

eTMF

EDC

Monitoring & Operational Plans

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

Job description

Biolinq Incorporated in San Diego, CA is seeking an experienced Clinical Research/Project Manager to drive clinical studies for a wearable biosensor platform. You will partner with sites, CROs, and internal teams to ensure protocol adherence, regulatory compliance, and on-time delivery across multiple studies.

Candidates bring 5+ years in clinical trial management, a STEM degree, and hands-on experience with CTMS, EDC, and TMF.