User Study Operations Manager

OSI Engineering, Inc.; Sunnyvale (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

OSI Engineering, Inc. in Sunnyvale, CA seeks an experienced health research operations professional to lead vendor communications, enrollment planning, and cross-functional project management.

The role drives scoping with vendors, manages budgets and invoicing, and ensures data quality across multiple global projects. The ideal candidate has 3+ years in health research management or engineering operations, with strong communication skills and a background in biomedical disciplines.

Qualifications

• Minimum 3+ years of experience in health research management, engineering operations, or relevant medical/clinical experience.
• Demonstrated ability to execute engineering research projects of varying sizes.
• Troubleshoots hardware and software challenges, analyzes engineering data to make study-level recommendations.
• Excellent written and verbal communication skills.
• BA/BS or higher in biomedical engineering, life sciences, or research-related discipline.
• Must have 2+ years of experience directly supporting technical operations in a research setting.

Responsibilities

• Lead communication between project teams and external vendors
• Develop enrollment and throughput plans
• Manage and communicate project status with cross-functional teams and external vendors
• Drive project scoping with research vendors including quotes, contracts, budget management, and invoicing
• Deliver high quality, low cost results
• Proactively, Identify and resolve risks to schedule and data quality
• Balance multiple projects across geographic regions throughout the globe
• Initiate, execute, and report status with keen focus on data quality and schedule
• Develop study documents like consent forms, statements of work, and SOPs
• Order, coordinate, and distribute study supplies to researchers – inclusive of device set-up as needed
• Facilitate communication and collaboration across a very multi-functional team including: engineering, studies, design teams, clinical, and regulatory
• Develop and train study personnel on data collection procedures, use of study systems and data monitoring processes

Skills

Vendor management

Project coordination

Cross-functional collaboration

Communication skills

Clinical/medical device research

Problem solving

Data analysis

Multi-project management

Education

BA/BS in biomedical engineering

Life sciences background

Advanced degree (plus)

Job description

A globally leading consumer device company based in Sunnyvale, CA is looking for

Responsibilities:

• Lead communication between project teams and external vendors


• Develop enrollment and throughput plans


• Manage and communicate project status with cross-functional teams and external vendors


• Drive project scoping with research vendors including quotes, contracts, budget management, and invoicing


• Deliver high quality, low cost results


• Proactively, Identify and resolve risks to schedule and data quality


• Balance multiple projects across geographic regions throughout the globe


• Initiate, execute, and report status with keen focus on data quality and schedule


• Develop study documents like consent forms, statements of work, and SOPs


• Order, coordinate, and distribute study supplies to researchers – inclusive of device set-up as needed


• Facilitate communication and collaboration across a very multi-functional team including: engineering, studies, design teams, clinical, and regulatory


• Develop and train study personnel on data collection procedures, use of study systems and data monitoring processes

Key Qualifications:

• Minimum 3+ years of experience in health research management, engineering operations, or relevant medical / clinical experience.


• Demonstrated ability to execute engineering research projects of varying sizes


• Troubleshoots hardware and software challenges, analyzes engineering data to make study-level recommendations


• Thrives by managing fast paced projects with minimal direction


• Excellent written and verbal communication skills


• Track record of managing vendors or contractors to deliver timely results


• Experience with clinical and/or medical device research


• Facilitated communication and collaboration across a very multi-functional team including: engineering, studies, design teams, clinical, and regulatory


• BA/BS or higher in biomedical engineering, life sciences, or research-related discipline.


• Must have 2+ years of experience directly supporting technical operations in a research setting. Advanced degree or experience analyzing engineering data is a plus, but not required.