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!
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- 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.