Clinical Systems Specialist Jobs

Ability to build and maintain positive relationships with management, peers, customers, and stakeholders

4+ years of experience working in clinical systems, including LIMS, eCTD, eTMF, EDC and eQMS

3+ years of experience working as a business analyst, including writing documentation and drafting workflow diagrams

Experience providing verbal and written presentations and communications

Knowledge of GCP and governing regulations, such as the TMF Reference Model, GAMP5 for Computer Systems Validation, and 21CFR Part 11

Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements

Support administration activities of clinical systems (e.g., User Management).

Experience in developing business specifications/requirements and user acceptance testing for computer systems.

Background of SAS programming or Data Management for clinical trials preferred

Good organization skills, ability to manage multiple tasks.

Work with end users and SMEs to define clinical data visualization business requirements and data elements

Experience with Tibco Spotfire (dashboard, visualization & report development) or other data review tools.

Associate's degree or an equivalent combination of education and experience (such as 2 additional years of relevant experience) required.

Minimum 2 years of clinical systems experience required.

Bachelor's Degree in Business, IT or Healthcare related field, preferred.

Tuition Reimbursement after 1 year of service.

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