Study Design Manager
As a Study Design Manager, you will help to build and manage a small, expert team of analyst / programmers working with pharmaceutical/life sciences clients to set up their clinical trials using our EDC tool. The Study Design Manager is responsible for the requirements gathering and software configuration functions required to meet the custom needs of each client and each study. People reporting to this position should be strong on analysis skills with the ability to do some programming in Javascript and HTML. This is a newly created position and offers the capability to help build the department and its standards.

Industry Experience Accepted:

• Clinical and/or Pharmaceutical experience highly preferred
• Data Manager accreditation is a big plus
• Experience with EDC preferred
• Experience working for a software company
• Minimum requirement: has worked in a regulated industry

Desired Skills:

• Experience interfacing with external clients
• Strong business analysis and GUI design skills
• Possess good communication skills and exhibits common sense
• Customer and process oriented
• Is a good mentor and a team player
• Enjoys working in a fast paced and dynamic environment
• Has Entrepreneurial Spirit

Work Experience / Capabilities:

• Has managed 5+ professionals
• Has 5+ years of management experience
• Lean Six Sigma skills are a plus
• Experience managing people and technology projects in a customer setting
• Ideally has knowledge of computer systems validation, 21 CFR Part 11, and other emerging requirements for regulated applications
• Preferred Technical skills: Javascript, HTML, SQL. Familiarity with relational databases such as SQL server

Education and Travel:

Please include your salary expectations to be considered for the position.  Apply in confidence to hr_operations@omnicomm.com

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