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Description
Purpose of role: Individuals filling the positions listed are responsible for expert execution in ARGUS Configuration or Change Management or Ad-Hoc Data Requests or Aggregate Data Tables for the Safety Information Management (SIM) system portfolio. Incumbent will partner with Business Technology and other business stakeholders to ensure ARGUS Configuration or Change Management or ad-hoc Data Requests or Aggregate Data Tables are fulfilled with data integrity according to defined requirements and timelines.
Primary Responsibilities: Supports utilization of IM systems and processes by responding promptly to end-user inquiries Investigates solutions to operations' issues and develops or contributes to written materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions. Liaise with business stakeholders and technical groups to define or gather business requirements, define new or improve business processes. Participate in developing and performing User Acceptance Testing (UAT) as required Lead small projects of short duration following established methodologies Liaise with business stakeholders and technical groups to provide/review impact assessments of business requirements and technical change which include the identification of processes and applications, required changes to these processes and applications, and alternatives to mitigate impact. Maintain a collaborative program of continuous improvement within the organization. Complete training in accordance with Safety information Management curriculum.
Required Technical Skills: Minimum of 3 years or relevant experience in data management with clinical safety data and business processes in the pharmaceutical industry, including an understanding of the drug development process. Knowledge of Safety, Regulatory, and/or Document management systems and technologies Experience with relational databases Knowledge of application system management and change control processes, application validation and implementation in a GxP environment Knowledge of Pharmaceutical metadata and standards Experience with query tools/data extraction techniques (eg, SQL, PL/SQL, Brio, MS Access)
Qualifications: Bachelor's Degree/equivalent employment experience in life sciences, or information management related discipline required. Knowledge of FDA, EMEA and ICH regulations is preferred. Demonstrated customer relationship skills and capabilities and collaboration on teams. Demonstrated ability to perform in a cross-functional environment. Strong verbal, written communication and presentation skills.
SKILLS
PL/SQL, SQL, MS Access
Synectics is an Equal Opportunity Employer.
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