Clinical Trial Manager
Location: San Diego, California, United States
Category: Medical and Clinical Affairs
About the Company
Abbott is a global healthcare leader committed to improving health outcomes through advanced diagnostics, medical devices, nutritionals, and branded generic medicines. With more than 114,000 professionals serving patients in over 160 countries, Abbott continues to deliver innovative technologies that support better living at every stage of life.
Why Join Abbott
Working at Abbott provides opportunities to contribute to impactful healthcare innovations while advancing your career. Employees benefit from:
Comprehensive career growth programs across global teams
Eligibility for free medical coverage through the Health Investment Plan (HIP) PPO
Competitive retirement savings plan with a high employer contribution
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education pathways
Recognition as a top employer for diversity, scientific leadership, and career advancement worldwide
Position Overview
The Clinical Trial Manager will be based in San Diego, California, supporting the Infectious Disease business within Abbott Rapid Diagnostics. This role is responsible for managing clinical studies that generate critical evidence for diagnostic solutions used globally in hospitals, laboratories, and clinics.
Key Responsibilities
Serve as the subject matter expert for clinical trials related to rapid in vitro diagnostic studies, including 510(k) OTC and dual 510(k)/CLIA waiver submissions
Lead the creation, review, and finalization of clinical protocols aligned with scientific and regulatory objectives
Manage full clinical trial operations, including start-up, site initiation, patient enrollment, monitoring, and study close-out
Oversee activities of clinical sites, reference laboratories, CROs, and external partners to ensure adherence to timelines, budgets, and quality standards
Manage clinical trial systems, including Electronic Data Capture (EDC) and electronic Trial Master File (eTMF), ensuring data quality and compliance
Collaborate with cross-functional teams such as Regulatory Affairs, Biostatistics, Quality Assurance, and Program Management
Participate in core team meetings to provide clinical expertise and strategic input
Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal SOPs
Support regulatory submissions and respond to queries from regulatory agencies
Identify and mitigate risks throughout the clinical study lifecycle
Mentor junior clinical staff and contribute to continuous improvement initiatives
Required Qualifications
Bachelor’s degree in Life Sciences or a related field; advanced degree (MS, MPH, PhD) preferred
Minimum 2 years of experience in clinical trial management, ideally within diagnostics or medical devices
Strong understanding of FDA regulations, including 21 CFR Parts 812, 50, and 11
Experience with 510(k) and CLIA waiver regulatory pathways
Proven experience managing multi-site clinical trials and working with CROs and external vendors
Proficiency with clinical trial systems including EDC and eTMF
Strong organizational, leadership, and communication skills
Ability to work effectively in a fast-paced, cross-functional environment
Preferred Qualifications
2+ years of IRB submission experience for in vitro diagnostics
Experience with 510(k) OTC and dual 510(k)/CLIA waiver regulatory pathways
At least 2 years of experience in clinical research or relevant laboratory-based scientific work
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