Clinical Data Manager

Abbott • Alameda, CA

23h • $90,000 - $180,000 • Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: The Opportunity This position works out On-Site at our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The Clinical Data Manager is responsible for performing data management tasks within defined established processes throughout the life cycle of the study, including startup, conduct and reporting phases ; experience with clinical or medical or research setting is REQUIRED. The Clinical Data Manager is also responsible for the training of peers in the applicable processes. This role is critical to the successful collection, reporting and analysis of clinical trial data as well as the mentorship of junior team members. What you’ll work on Assist in translation of clinical study requirements into trial Casebook. Develop and maintain Data Management Plans in areas such as data workflow and data transfers. Develop edit check specifications for the automated cleaning of data management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues. Conduct user acceptance testing of study databases, reports, study notifications and database customizations. Resolve problems with databases. Develop study specific data listings. Identify opportunities for improvement and proposed solutions, develop procedures and train to new processes. Experience utilizing Electronic Data Capture systems (OpenClinica), Veeva Vault eTMF, and SAS. Mentor junior team members in the roles and responsibilities of the Clinical Data Management Analyst. Train participating staff on technical procedures and software usage.

Requirements

• Minimum 4+ years in a clinical or medical or research setting
• Bachelors degree required - Education and work experience in computer science, life sciences or technical field.
• Expert in data collection best practices for clinical trials.
• Expert knowledge of global clinical operations.
• Expert in the use of SQL to query data sets based on defined parameters.
• Intermediate to advanced therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.
• Intermediate to advanced medical knowledge related to common medical histories, medical terminology, diagnostics (imaging, laboratory), and medications (class, dose, route).
• Certified Clinical Data Manager (CCDM) or equivalent.

Responsibilities

• Assist in translation of clinical study requirements into trial Casebook.
• Develop and maintain Data Management Plans in areas such as data workflow and data transfers.
• Develop edit check specifications for the automated cleaning of data management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues.
• Conduct user acceptance testing of study databases, reports, study notifications and database customizations. Resolve problems with databases.
• Develop study specific data listings.
• Identify opportunities for improvement and proposed solutions, develop procedures and train to new processes.
• Experience utilizing Electronic Data Capture systems (OpenClinica), Veeva Vault eTMF, and SAS.
• Mentor junior team members in the roles and responsibilities of the Clinical Data Management Analyst. Train participating staff on technical procedures and software usage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level