Clinical Trial Manager – Infectious Disease Diagnostics
Location: San Diego, California, USA (Onsite)
Category: Medical & Clinical Affairs
Experience Required: Minimum 2 years in clinical trial management or medical device diagnostics
Employment Type: Full-time
Company Overview
Abbott is a global healthcare leader dedicated to transforming lives through innovative diagnostics, medical devices, nutrition, and branded generics. Operating in over 160 countries, Abbott’s solutions improve patient care worldwide. The Infectious Disease Division at Abbott Rapid Diagnostics delivers diagnostic tests and instruments used in hospitals, laboratories, and clinics, providing crucial information for early patient care decisions.
Role Overview
Abbott is seeking a Clinical Trial Manager to lead and manage clinical trials for rapid in-vitro diagnostic products, including 510(k) OTC and dual 510(k)/CLIA waiver regulatory pathways. This role will oversee end-to-end clinical operations, from protocol development and site initiation to data management and regulatory compliance. The Clinical Trial Manager serves as a key member of cross-functional teams, contributing clinical insights to support product development, regulatory submissions, and strategic decision-making.
Key Responsibilities
Lead design, development, and review of clinical protocols to achieve scientific and regulatory objectives.
Oversee clinical trial operations including site start-up, initiation, patient enrollment, monitoring, and study close-out.
Manage external partners including clinical sites, reference laboratories, and Contract Research Organizations (CROs).
Supervise electronic data capture (EDC) systems and electronic Trial Master File (eTMF) platforms to ensure compliance and data integrity.
Collaborate with cross-functional teams, including Regulatory Affairs, Quality Assurance, Biostatistics, and Program Management.
Support regulatory submissions with accurate clinical documentation and responses to agency queries.
Identify, evaluate, and mitigate risks throughout the clinical trial lifecycle.
Mentor junior clinical staff and contribute to continuous process improvement initiatives.
Ensure compliance with Good Clinical Practice (GCP), internal SOPs, and applicable FDA regulations.
Participate in core team meetings to provide clinical insights and strategic input for product development decisions.
Education & Experience
Required Qualifications:
Bachelor’s degree in Life Sciences or a related field. Advanced degrees (MS, MPH, PhD) preferred.
Minimum 2 years of experience in clinical trial management, preferably in diagnostics or medical devices.
Strong knowledge of FDA regulations, including 21 CFR Parts 50, 11, and 812.
Experience with 510(k) and CLIA waiver regulatory pathways.
Proven track record in managing multi-site clinical trials and collaborating with CROs and external vendors.
Proficiency with clinical trial systems such as EDC and eTMF.
Ability to travel up to 10%.
Preferred Qualifications:
Experience with IRB submissions for in-vitro diagnostic products.
Hands-on experience in conducting clinical research or laboratory-based scientific studies.
Strong organizational, leadership, and communication skills.
Ability to work independently and collaboratively in fast-paced, cross-functional environments.
Why Join Abbott
Work on cutting-edge diagnostic technologies that impact global healthcare.
Access to professional growth, career development, and advanced training programs.
Competitive compensation with base pay of $90,000 – $180,000.
Comprehensive health, wellness, and retirement benefits including medical, dental, vision, and 401(k) matching.
Dynamic work environment that values diversity, inclusion, and innovation.
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