The Clinical Systems Specialist is responsible for providing support to internal end users for the Clinical Systems including training, troubleshooting, reporting, and managing user access.
More specifically, the Clinical Systems Specialist:
Manage and support the Clinical Systems, including system implementation, set-up, maintenance, support, training, testing, and documentation;
Manage user access to the system;
Program reports and dashboards;
Assess the training needs of end users and design effective training materials and techniques for individuals with different levels of computer literacy;
Conduct software application trainings to end users;
Research, interpret, explain and apply information from computer software technical manuals and guides, videos and online materials;
Develop an in-depth understanding of operational workflows in order to develop and implement system processes;
Support end users by providing technical support, troubleshooting and identifying opportunities for system improvements;
Communicate with vendor for system support, development, improvement, and maintenance;
Respond to client audits and questions;
Prepare, execute, and document all aspects of Validation Testing for the system;
Provide routine or ad-hoc reports to executives;
Collaborate with other Department/Teams to integrate processes/systems;
Review billing requests from Vendors.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements:
Post-secondary education;
3-5 years of relevant experience;
Previous experience working in a CRO, pharmaceutical or biotechnology industry, an asset;
Proven expertise working with Sharepoint (support, configuration, and programming);
Excellent knowledge of the Microsoft Office Suite;
Good knowledge of MS Reporting Services;
Good understanding of working in a controlled and validated environment;
Ability to develop training material and conduct training sessions for end users;
English- excellent oral and written skills;
Good organizational and prioritization skills;
Ability to work in a fast-paced environment;
Meticulous attention to detail and accuracy;
Ability to troubleshoot and resolve issues effectively;
Ability to work in a team environment and establish good relationships with colleagues.
Good knowledge of good clinical practices, GxP and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
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