Clinical Data Manager 3

ASRC FederalReston, VA

About The Position

ASRC Federal, a leading government contractor focused on missions in space, public health, and defense, and an Alaska Native owned corporation, is seeking a Clinical Data Manager 3 for its Agile Decision Sciences LLC team. This role involves managing the delivery of high-quality data from project start-up to closeout across multiple projects. The successful candidate will independently perform project-specific quality control and quality assurance tasks, ensuring adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, SOPs, and Working Instructions. Key responsibilities include managing patient protocol information, reviewing protocols, contributing to database and form design, testing new processes and systems, processing and validating data, performing data abstraction and entry, developing clinical data reports, and preparing data for monitoring agencies. The position also requires maintaining client communication and demonstrating initiative and autonomy, as well as training, mentoring, and coaching other clinical data managers.

Requirements

  • A bachelor’s degree
  • 2-4 years of experience in a related or applicable field, or an equivalent combination of education and experience.

Responsibilities

  • Manage the delivery of high-quality data from project start-up and planning to project execution and project closeout on several projects
  • Independently perform project specific quality control and quality assurance tasks on all projects
  • Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions
  • Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously
  • Contribute to the design of the databases and forms, ensuring they meet requirements for entry and reporting of clinical data of varying complexity
  • Test new processes and systems for the management of data in clinical trials
  • Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures
  • Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions
  • Perform data abstraction and data entry on several different protocols into multiple clinical research databases
  • Develop and extract patient clinical data reports for publications and presentations
  • Possess proficiency with clinical databases and report tools
  • Identify project specific reports and assist in the development of these reports
  • Prepare, review, and submit clinical data to monitoring agencies
  • Maintain client communication regarding data management project status and review key project questions with clients
  • Demonstrate a significant amount of initiative, autonomy, and proficiency in all areas above
  • Train, mentor, and coach other clinical data managers

Benefits

  • competitive pay and benefits packages
  • health care
  • dental
  • vision
  • life insurance
  • 401(k)
  • education assistance
  • paid time off including PTO, holidays, and any other paid leave required by law
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