Bachelor's or master's degree in a scientific field or equivalent experience
5+ years of experience in the medical device industry
Experience in clinical research with a focus on study management or execution
Management experience is preferred
Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
Responsibilities
Serve as primary contact for sponsors and communicate study updates
Guide team members on timelines and study activities
Collaborate with sponsors to select and train study sites
Ensure compliance with protocols and mitigate study risks
Coordinate with internal departments and third-party vendors
Provide training to entry-level team members
Participate in project team meetings as needed.
Benefits
Complimentary paid parking
Comprehensive health insurance (medical, dental, and vision)
Paid parental leave
Short- and long-term disability benefits
401(k) plan with company match
Tuition reimbursement
At least 12 paid company holidays
Access to an on-site gym.
Full Job Description
What does the role require?
Serve as the primary sponsor contact, communicate key study updates, and ensure alignment among sponsors, Bright leadership, and study team members.
Direct team members on timelines, strategies, and study activities; develop and manage protocols, plans, and study documents; ensure accurate, timely study reporting.
Work with sponsors and site personnel to identify, qualify, select, initiate, and train study sites; collaborate with Clinical Research Associate (CRAs) to resolve monitoring findings.
Ensure adherence to protocols, Good Clinical Practice (GCPs), regulatory requirements, IRB/EC standards, and internal procedures; identify and mitigate study risks; support audits and inspections.
Coordinate with departments such as Data Management and Regulatory; manage activities with third-party vendors (e.g., translation services, core labs); facilitate or assist with investigator, committee, and study team meetings.
Provide training and guidance to entry-level team members and participate in staff and project team meetings as needed.
Qualifications
Education
Bachelor's or master's degree in a scientific field, or equivalent work experience
Experience
At least 5+ years of medical device industry, clinical research experience in a study management or execution role; Management experience preferred
Benefits
Salary range: $90,000 - $125,000
Complimentary paid parking, comprehensive health insurance (medical, dental, and vision), paid parental leave, short- and long-term disability benefits, a 401(k) with company match, tuition reimbursement, at least 12 paid company holidays, and access to an on-site gym.
