Senior Clinical Site Lead at Abbott

Houston, Texas, United States

Abbott Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
HealthcareIndustries

Requirements

  • Advanced subject matter resource in protocol execution
  • Multiple product and disease state knowledge
  • Procedure support (as needed)
  • Procedure outcomes and early indication of trends
  • Clinical trial enrollment
  • ICH-GCP and clinical research application
  • Adheres to specified site nomination, qualification, and startup processes
  • Leads ongoing training/retraining of all site stakeholders
  • Continuously reviews, manages, and influences all aspects of site's recruitment and data collection performance
  • Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc
  • Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards
  • May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee
  • Recognized leader and expert in clinical territory
  • Provides support, mentoring, and guidance to other clinical site management colleagues
  • Supports key projects/initiatives in Global Clinical Operations and/or Business Units

Responsibilities

  • Develop and maintain a productive clinical territory
  • Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels, and required data quality
  • Understand and assess investigators' interests and qualifications
  • Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code
  • Maintain open communication and relationships with key site personnel
  • Provide ongoing technical support to customers and field staff
  • Facilitate communication between clinical sites and other Abbott clinical staff
  • Manage all aspects of study lifecycle, including start-up process and site initiation visits
  • Train facility staff regarding protocol requirements and technology
  • Develop site-specific strategies to promote patient enrollment
  • Identify site successes and challenges and assist in implementing techniques to promote study goal achievement
  • Continuously evaluate site study performance and provide timely feedback to site
  • Attend study procedures and follow-ups when indicated
  • Develop site-specific strategies to avoid deviations
  • Utilize appropriate operational metrics to minimize screen failure, attrition rate, etc

Skills

Protocol Execution
Clinical Trial Enrollment
ICH-GCP
Clinical Research Application
Regulatory Requirements
Good Clinical Practice
Data Collection
Discrepancy Resolution
Site Initiation
Site Monitoring
Training
Mentoring
Study Design
Site Payments
Site Audits
Document Review
Study Documents Preparation
Submission

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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