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System One Data Manager in Philadelphia, Pennsylvania

Job Title : Data Manager

Location: Remote

Type: Direct

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 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.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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