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Job: Clinical Data Manager

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Job Description

Oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout. Manages the day- to-day data management project activities including, but not limited to, timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Analysts.

Primary Responsibilities:

  • Lead study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
  • Allocate and prioritize workloads for multiple projects (media control, data entry, pre entry review and query management tasks)
  • Serve as a primary resource for issues pertaining to data management
  • Serve as an interim resource for issues pertaining to the study in the absence of the Senior Clinical Data Manager or other SDC management
  • Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities
  • Mentor all levels of Clinical Data Analysts in their job responsibilities
  • Maintain quality control of the data, project deliverables and closeouts
  • Oversee the review of medical coding for validity and completeness
  • Assume any task outlined in all levels of the Clinical Data Analyst job descriptions, as needed
  • Adhere to all aspects of the SDC's quality system
  • Comply with SDC's data integrity & business ethics requirements
  • Perform other related duties incidental to the work described herein

Skills / Requirements

Required Skills and Attributes:

  • Exceptional working knowledge of clinical trials and data management role in the clinical trials process
  • Excellent organizational skills
  • A minimum of 1 year staff mentoring and leadership experience
  • Strong leadership capabilities
  • Strong delegation abilities
  • Highly effective communication skills, both written and verbal
  • Technical skills including: Oracle clinical or other relational databases, Microsoft Office
  • Additional required skills include the following: CRF design, MS Project, and analytical capabilities.

Education or Equivalent Experience:

  • Master's degree in engineering, applied or life science and at least six (6) months of experience in clinical data management or a Bachelor's degree in engineering, applied or life science and a minimum of five (5) years of experience in clinical trials.