Job Posting for Clinical Data Associate at Adagio Medical
JOB TITLE: Clinical Data Associate
DEPARTMENT: Clinical Affairs
REPORTS TO: Director, Clinical Affairs
POSITION SUMMARY
The primary role of the Data Management Associate (DMA) is to provide expertise for managing data and meeting the objectives of a clinical study. This includes supporting the development and implementation of a Data Management Plan (DMP) and assistance with implementing the process for data collection utilizing an electronic data capture system. Training of all internal and site research personnel will be a requirement throughout the conduct of the study. All support for data management will be in compliance with applicable regulatory standards, Internal Review Board/Ethics Committees IRB/EC policies and procedures and Adagio Medical internal requirements. The DMA is expected to provide any cross-functional support needed for departments within Adagio Medical in an effort to achieve desired corporate goals.
DUTIES AND RESPONSIBILITIES
Complete data management activities to meet project timelines from study start up to database lock.
Data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting.
Assists with data management start up activities, database cleaning and lock activities including review and development of case report forms, data management plans, and database development.
Reviews and processes clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.
Assist with identifying data trends and/or issues.
Work closely with Clinical Affairs project team members to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
Assist completing requests when working with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data.
Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
Participate in cross functional team meetings as requested
Manage multiple and varied tasks, prioritize workload with attention to detail.
Other duties as assigned.
REPORTING
This position will report directly to the Director, Clinical Affairs. Specific duties will be determined and coordinated in conjunction with the company needs and strategic plans. Duties may change to support revisions to corporate goals and immediate needs.
JOB QUALIFICATION REQUIREMENTS
Minimum – Bachelor’s Degree in a related field or High School equivalent with at least 6 years experience working in a clinical research data handling environment with relevant practical medical device experience
Minimum – two (2) years industry experience in data management with a medical device/pharmaceutical/biotechnology company
Minimum – one (1) year experience supporting the day-to-day data management activities of a clinical study with an EDC system
Minimum – Work experience demonstration of attention to detail while maintaining work efficiency, and ability to prioritize activities across various assigned study tasks.
Minimum – Work experience demonstration of data listing review and query management
Minimum – Knowledge and use of Microsoft applications
Desirable – Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, FDA guidelines, and GCDMP.
Desirable – Prior experience with a start-up medical device company
Desirable – Prior experience with Medrio, Medidata, IBM, or other similar electronic database systems.
Desirable – Certification from an accredited GCP training program and a HIPPA compliance program
Salary.com Estimation for Clinical Data Associate in Laguna Hills, CA
$76,052 to $97,978
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