Associate Clinical Data Manager (on-site) at Abbott

Sylmar, California, United States

Abbott Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

  • In-depth clinical operations and therapy-specific knowledge
  • Ability to lead and facilitate cross-functional teams
  • Expertise in protocol development, risk evaluation, and mitigation strategies
  • Knowledge of critical data, processes, and systems (e.g., CRF design, edit checks, data listings, clinical database setup)
  • Skills in study database development, including identifying, programming, and testing edit checks
  • Proficiency in complex data review, analysis, query resolution, and escalation management

Responsibilities

  • Lead ongoing evaluation of risk through in-depth review of protocol and plan documentation
  • Discuss and validate Critical Data, Critical Processes, and risk-related findings with cross-functional workgroups
  • Develop systems and process-based controls to mitigate identified risks
  • Lead cross-functional teams during protocol development to identify and document critical data for study reliability and human subject protection
  • Manage development and revision of critical processes (e.g., CRF design, edit checks, data listings, clinical database setup)
  • Identify and evaluate residual risks to critical study data and supervise additional mitigations (e.g., focused data cleaning, quality activities, targeted site instructions, Central and Site Monitoring plans)
  • Lead the Clinical Project Team in developing Case Report Forms
  • Partner with the Study Database Manager through study database development and release
  • Conduct complex review and analysis of accumulating subject data
  • Resolve discrepant or aberrant data points via queries to study sites
  • Identify systemic or significant data quality issues requiring escalation and manage escalation efforts

Skills

Clinical Data Management
Data Management
Healthcare Data
Clinical Trials

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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