Careers - QST Consultations, LTD.

Senior Clinical Data Manager

Job Title
Senior Clinical Data Manager
Location
Grand Rapids,  MI
Other Location
Description

Located in beautiful Western Michigan between Grand Rapids and the shores of Lake Michigan, ​QST Consultations, LTD. is a full-service clinical research organization (CRO) providing full clinical operations, data management, statistical analysis support and medical writing services to the drug and device development industries. Founded in 1974, the company has collaborated with clients on many successful Phase I-III and Post-Marketing clinical trials designed to support 510(k), PMA, ANDA, and NDA submissions, along with ongoing marketing activity support. QST’s primary focus is to meet the goals of each client through personalized service and technical expertise; we currently work with a range of sponsors that extend from small start-up organizations to well-established leaders in the pharmaceutical industry.

 

As the company continues to grow, there is an incredible opportunity for a Senior Clinical Data Manager to serve as the technical leader and primary contact for all data management projects and activities. Our ideal candidate can be office-based or remote-based.

 

Are you ready to join the team?

 

You will be responsible for:

  • Providing oversight and direction of data management activities
  • Serving as the project and client representative
  • Identifying data management activities outside the scope of contracted work and notifying project manager
  • Developing database design, edit checks, and annotated case report forms according to study specifications
  • Reviewing randomization plans from statistical services group
  • Coordinating the development and testing of external edit checks designed to facilitate data review and discrepancy management activities
  • Performing quality control of database builds and data management documentation
  • Presenting database training to study staff and sites both web-based and occasionally in person as part of an investigator meeting
  • Offering solutions to address quality concerns identified through data review trends
  • Building training materials, leading training activities, and mentoring staff as needed
  • Collaborating with other team members and client representatives to support the study set-up, maintenance, and project closeout of data management activities
  • Keeping client and team members aware of potential project risks and craft mitigation strategies and proactively addressing issues

 

You must:

  • Have a bachelor’s degree with at least five (5) years of relevant industry experience or a high school diploma and a minimum of seven (7) years of related experience
  • Be very detail-oriented, thorough, and organized
  • Have demonstrated project management experience and be able to perform under tight timelines and balance conflicting priorities
  • Have versatile communication and strong interpersonal skills, focusing on clients’ needs
  • Be comfortable working in a highly regulated environment and have an expert understanding of relevant regulatory requirements
  • Be proficient in Oracle InForm
  • Have exposure to Medidata Rave as a plus

 

Why QST?

Recognized as a top company to watch in Michigan, QST is a small employee-owned company that has been making a big impact in the CRO industry over the last 40 years. If you desire a rewarding career where you can make a difference, we encourage you to apply today!

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