Trial Programmer Specialist III

Work Schedule

Environmental Conditions

Job Description

Provides technical leadership and guides the Pharmacovigilance business to refine and automate business processes and establish system needs. Gathers analyzes and documents user requirements for various business initiatives. Liaisons with IT and ensures requirements are appropriately translated into design specifications for systems and reports. Analyzes systems support issues and enhancements requests and identifies workarounds or works with IT to design solutions.

Major Job Responsibilities:

Managed access configurations across Argus suites including Admin and Axway .

Handling Argus upgrade initiatives and data migration projects.

Configured Product/Codelist Product Family and Study/License/Product setups while thoroughly documenting planned

and routine changes to ensure alignment with end-user requirements.

Solicits and documents requirements for various project initiatives analyzes those requirements works with IT and ensures that requirements are properly translated into design specification for systems and/or reports.

Works independently and defines streamlines and automates business processes. Provides support in relevant SOP/WPD development.

Solves complex support issues and analyzes root cause for enhancement opportunity and identifies workarounds or works with IT to design solutions.

Liaises with the business and IT and ensures that all the components and services required for various project initiatives are properly delivered in a timely manner.

Trains end users for systems and processes. Mentors guides and trains Safety Systems Analysts and Safety Systems Administrators. May serve in a lead capacity.

Attends client meetings when needed and supports the development of proposals for new business.

Stays abreast of the latest developments in related technologies; Shares knowledge with team members. Performs other duties as assigned.

Education / Experience:

Bachelors degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).

Knowledge Skills and Abilities Required:

In depth knowledge of Pharmacovigilance processes including applicable SOPs ICH GCP current pharmacovigilance regulations and local guidelines

Knowledge of document management concepts and systems and workflow/process automation concepts and tools

Advanced technical & business understanding of safety and clinical systems

Client-focused approach with strong interpersonal skills

Strong written and verbal communication skills

Robust problem solving and analytical skills

Strong planning and organizational skills

Highly proficient in Microsoft Office applications

Ability to multi-task with strong attention to detail

Ability to lead and mentor others within a project team

Proven ability to work within a team or independently as required