🧬 Position Title: Clinical Trial Manager
Location: United States – California – San Diego
Category: Medical and Clinical Affairs
Company: Abbott
🌍 About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Its diverse portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues across 160+ countries, Abbott is committed to advancing health through innovation.
💼 Working at Abbott
Abbott offers an empowering environment where you can:
Do meaningful work that impacts lives globally
Grow your career with international opportunities
Care for yourself and your family with excellent benefits
Be your authentic self in an inclusive workplace
Employee Benefits Include:
Free medical coverage under the Health Investment Plan (HIP) PPO
High employer contribution to retirement savings plan
Tuition reimbursement and Freedom 2 Save student debt program
FreeU education benefit – affordable pathway to earn a bachelor’s degree
Recognized by Fortune as one of the World’s Most Admired Companies
Named among the Best Places to Work for diversity, mothers, female executives, and scientists
🚀 The Opportunity
The Clinical Trial Manager (CTM) will be based in San Diego, CA, within Abbott’s Infectious Disease Division (Abbott Rapid Diagnostics).
You will play a vital role in managing rapid in vitro diagnostic (IVD) clinical trials — supporting studies that aid in detecting diseases such as infectious disorders, cancers, heart conditions, and more.
🧩 Key Responsibilities
Serve as the subject matter expert (SME) for rapid IVD clinical studies, focusing on 510(k) OTC and dual 510(k)/CLIA waiver submissions.
Lead the development, review, and finalization of clinical protocols aligned with regulatory and scientific objectives.
Manage all aspects of clinical trial operations, including:
Study start-up
Site initiation
Patient enrollment
Monitoring and close-out
Oversee activities of clinical sites, reference labs, CROs, and external vendors — ensuring compliance with timelines, budgets, and quality.
Supervise and manage Electronic Data Capture (EDC) and electronic Trial Master File (eTMF) systems for data integrity and compliance.
Collaborate cross-functionally with Regulatory Affairs, QA, Biostatistics, and Program Management teams.
Contribute to strategic decision-making through core team participation.
Ensure adherence to GCP, FDA regulations, and internal SOPs.
Provide clinical documentation for regulatory submissions and respond to agency queries.
Identify and mitigate risks throughout the trial lifecycle.
Mentor junior staff and promote continuous process improvement.
🎓 Required Qualifications
Bachelor’s degree in Life Sciences or related field
(Advanced degree — MS, MPH, or PhD preferred)
Minimum 2 years’ experience in clinical trial management, preferably in diagnostics or medical devices
Strong understanding of FDA regulations (21 CFR Part 812, 50, and 11)
Experience with 510(k) and CLIA waiver pathways
Proven success in multi-site trial management and vendor oversight
Proficiency in EDC and eTMF systems
Excellent organizational, communication, and leadership skills
Ability to work independently in a fast-paced, cross-functional environment
🌟 Preferred Qualifications
2+ years’ experience with IRB submissions and 510(k) OTC/dual 510(k)-CLIA waiver regulatory pathways
2+ years’ experience in conducting clinical research or related scientific laboratory work
💰 Compensation
Base Pay Range: $86,700.00 – $173,300.00
(Range may vary by specific location)
🔗 Additional Information
Learn more about Abbott’s employee benefits:
👉 www.abbottbenefits.com
Connect with Abbott:
🌐 www.abbott.com
📘 Facebook
🐦 Twitter @AbbottNews
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