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!

• 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 i mproving 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.

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