Sr Clinical Project ManagerMorris Plains, NJ
Axians redtoo recently brought its almost 30 years of experience in IT and consulting solutions to the Axians family. As both strategic advisors and a full-service IT provider, our customers' core businesses benefit through our optimization of their business processes and effectively implementing their technology investment.
We are seeking a Sr. Business/Project Analyst to join our fast growing and dynamic global IT consulting company.
Our key Drug Discovery/BioPharma client is in need of a Sr Business/Project Analyst to support their Clinical Operations, Clinical Development and Regulatory/Pharmacovigilence spaces. He/she will be responsible for overseeing activities such as gathering, analyzing & prioritizing functional as well as non functional requirements in order to facilitate the development of new systems and/or technical solutions with regards to complex Business issues. One will be expected to develop comprehensive Domain Business Process Models which will then be used to “guide” continuous improvement initiatives and an overall understanding of the Business Process key to the Clinical space.
From Day 1, the selected individual will be required to work closely with key Business Stakeholders, Subject Matter Experts, IT Peers, Validation Personnel and others in order to “identify” & “document” the Business Requirements needed to project possible solutions for Data Processes, Interface Controls, Systems, Outputs and more. He/she will work in conjunction with other internal/external Domain Business Analysts in the creation of Standardized Templates & Methodologies to be used/practiced across the entire Enterprise.
Desired Skills and Requirements
All candidates being readied for submittal must possess current work experience from within the Pharmaceutical/Biotechnology industry, particularly in how it “operates”. He/she must be able to “demonstrate” a strong Domain intellect while understanding how technology solutions can improve/enhance our client’s existing processes and overall Business results. All candidates must be well versed in Global GxP as well as Computer System Validation processes. When in the Regulatory space, all candidates should be able to demonstrate proficiency when being guided by ICH E6(R2), 21 CFR Part 11, Annex 11 and GAMP 5.
Must be able to work on multiple, unrelated initiatives at the same time while maintaining accuracy and quality with one’s Deliverables. Must be able to “identify” opportunities to maintain Clinical synergy as well as integration across subject areas. Finally, all candidates must demonstrate excellent verbal/written skills with an ability to “engage”with multiple levels of the organization.
Competitive salary and benefits packages