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Abbott · 7 hours ago

Clinical Trial Manager

San Diego, CA

Full-time

Onsite

Entry, Mid Level

$87K/yr - $173K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Clinical Trial Manager will oversee clinical trial operations, manage protocol development, and ensure compliance with regulatory standards while collaborating with cross-functional teams.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

H1B Sponsor Likely

Responsibilities

Oversee clinical protocol development and review to meet required targets

Start up the enrollment and close out activities for clinical sites, reference lab, CRO and other management. Supervision and management of EDC and eTMF

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

Travel up to 10%

Qualification

Clinical trial managementFDA regulations knowledgeEDCETMF proficiencyVitro diagnostics experienceIRB submissions experienceOrganizational skillsCommunication skillsLeadership skillsCollaborative skills

Required

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

10% Travel for the role

Preferred

2 + years of experience with IRB submissions for In vitro diagnostics and regulatory submission pathways for 510(k) OTC and dual 510(k) and CLIA waiver pathways

Minimum of 2 years' experience in conducting clinical research or related scientific laboratory skills

Excellent organizational, communication, and leadership skills

Ability to work independently and collaboratively in a fast-paced, cross-functional environment

Benefits

Free medical coverage in our Health Investment Plan (HIP) PPO medical plan

An excellent retirement savings plan with a high employer contribution

Tuition reimbursement

The Freedom 2 Save student debt program

FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

Company

Abbott

Glassdoor3.8

Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.

Founded in 1888

Illinois City, Illinois, USA

10001+ employees

https://www.abbott.com

H1B Sponsorship

Abbott has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (1)