Study Manager, Preclinical Research

Pharmaron • Carlsbad, CA

1d • Onsite

About The Position

The Study Manager, Preclinical Research plays a critical role in coordinating and executing preclinical studies supporting the development of innovative medical devices. This position serves as an operational leader for study execution, ensuring all activities are conducted efficiently, compliantly, and in alignment with study protocols, regulatory standards, and internal SOPs.
This role is ideal for candidates with hands-on in vivo research experience who are looking to expand their responsibilities in study coordination, preclinical operations, and medical device research within a CRO environment.

Requirements

• Bachelor's degree in Biology, Animal Science, Biomedical Sciences, or related field
• Minimum 2–3 years of hands-on experience in an in vivo preclinical research environment
• Experience supporting large animal preclinical studies or medical device research preferred
• Experience working in a GLP-regulated laboratory environment, ideally within a CRO
• Background in lab animal research (in vivo) with working knowledge of preclinical techniques and modalities
• Experience coordinating study schedules, personnel, and study logistics is highly desirable
• Strong organizational skills with ability to manage multiple concurrent studies
• Proficiency with Microsoft Office tools including Excel, Word, Outlook, and Teams
• Strong communication skills, attention to detail, and ability to work in a fast-paced team environment

Nice To Haves

• Experience with laboratory data systems (eQCM, Vivarium+ or similar systems) is a plus

Responsibilities

• Coordinate and manage day-to-day execution of preclinical studies supporting medical device development
• Collaborate with Study Directors and research teams to develop and maintain study schedules and project timelines
• Coordinate operating room schedules and research personnel to ensure efficient study execution
• Ensure all study activities, animal observations, and documentation are completed in accordance with study protocols, SOPs, and regulatory requirements
• Support in vivo procedures including surgical support, necropsy, biological sample collection, imaging, and data documentation as needed
• Review study documentation and data for accuracy and completeness prior to QC submission
• Maintain study schedules and master tracking tools for all ongoing study activities
• Coordinate shipment and tracking of biological samples and study materials
• Maintain inventory of study supplies and ensure materials are available to support planned studies
• Train and mentor junior research staff on in vivo techniques and study procedures
• Assist with preparation of study reports, protocols, SOPs, amendments, and regulatory documentation
• Support IACUC protocol submission, implementation, and compliance monitoring
• Monitor equipment functionality and coordinate maintenance when needed
• Communicate study updates and progress with internal teams and stakeholders
• Address client and internal requests for information in a timely and accurate manner
• Perform additional duties as required to support study execution and departmental objectives

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level