Data Manager Job at System One Holdings, LLC, Philadelphia, PA

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  • System One Holdings, LLC
  • Philadelphia, PA

Job Description

Job Title : Data Manager

Location: Remote - Must be US Based in EST

Type: Direct - Full time salaried



Overview
Our clinical partner wants to hire a Data Manager for a Direct Hire role. The best candidate for this role will have previous industry experience in oncology specifically.If you want to join a great company impacting cancer research, please apply!

Responsibilities

  • Responsible for assisting in the management and daily oversight of data management staff.
  • Development of data management and regulatory use related SOP and work instructions.
  • Mentors and trains data management staff.
  • Serves as a liaison to industry sponsors when collaborating on data management related deliverables.
  • Serves as a liaison to Medidata Rave for Rave-related initiatives.
  • Assists with study building and liaises with study builders to ensure communication flow when updates to forms are needed on a study specific and global level.
  • Develops and/or reviews standard library of CRFs, edit checks, and custom functions.
  • Serves as SME for CDASH/CDISC compliance as well as contained SDTM mapping
  • Assists with and oversees implementation of each clinical study database into production.
  • Oversees projects and assignment of projects as necessary.
  • Assists the Senior Director by providing input into improving processes and implementation of new procedures.
  • Oversees the maintenance of all Data Management department SOPs.Authors related SOPs, WI, and other documentation and tools to enhance the functioning of the Data Management department.

Requirements

  • A minimum of five (5) years of experience in data management for clinical research trials (oncology).
  • Data management experience in a pharmaceutical company or CRO.
  • Experience in oncology clinical research.
  • Thorough understanding of data collection and management practices related to oncology-specific clinical trials.
  • Strong Medidata Rave experience.
  • Understanding and familiarity with regulatory use related to data management (including global data management experience) preferred.
  • Computer literate in Microsoft Office and other Coalition required and related systems.
  • A bachelor's degree from an accredited institution of higher education or equivalent work and/or relevant professional experience is required.
  • Medidata certifications in data management.
  • Exemplary leadership, interpersonal, communication, organizational and education skills.
  • This role necessitates self-direction, motivation, strict attention to detail and problem-solving abilities along with time management and delegation skills.
  • The ability to multi-task and set priorities is also required.

#M3

Job Tags

Full time, Remote job,

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