Clinical Trial Manager at Abbott

San Diego, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical DevicesIndustries

Requirements

Bachelor’s degree in life sciences or related field; advanced degree (e.g., MS, MPH, PhD) preferred
Minimum of 2 years of experience in clinical trial management, preferably in diagnostics or medical devices
Strong knowledge of FDA regulations, including 21 CFR Part 812, 50, and 11, and experience with 510(k) and CLIA waiver pathways
Proven track record in managing multi-site clinical trials and working with CROs and external vendors
Proficiency with clinical trial systems such as EDC and eTMF
Excellent organizational, communication, and leadership skills

Responsibilities

Serve as the clinical trial subject matter expert for rapid in vitro diagnostic studies, with a focus on 510(k) OTC and dual 510(k)/CLIA waiver submissions
Lead the development, review, and finalization of clinical protocols to meet regulatory and scientific objectives
Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out
Oversee clinical site activities, reference laboratories, contract research organizations (CROs), and other external partners to ensure compliance with timelines, budgets, and quality standards
Supervise and manage electronic data capture (EDC) systems and electronic trial master file (eTMF) platforms to ensure data integrity and regulatory compliance
Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Biostatistics, and Program Management
Participate in core team meetings to provide clinical insights and contribute to strategic decision-making
Ensure adherence to Good Clinical Practice (GCP), applicable regulatory requirements, and internal SOPs
Support regulatory submissions by providing clinical documentation and contributing to responses to regulatory agencies
Identify and mitigate risks throughout the clinical trial lifecycle
Mentor and guide junior clinical staff and contribute to continuous process improvement initiatives

Skills

Clinical Trials

510(k)

In Vitro Diagnostics

OTC Studies

Regulatory Affairs

Trial Management

Infectious Diseases

Diagnostics

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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