Job Description

xe2x9exa2 Responsible for creating URS and functional requirement specs in Clinical Reporting and Analyticsxe2x9exa2 Create wire-frames and mock-ups for Clinical reportsxe2x9exa2 Responsible for communicating with Clinical Data Management & Medical Reviewers and document the clinical reporting needs.xe2x9exa2 Should be up-to-date with all the Saama product features and releases.xe2x9exa2 Should analyze and understand current business processes, events and flows in Clinical Trial Developmentxe2x9exa2 Should be responsible for Clinical Project Support and acts as a Clinical Subject Matter Expertxe2x9exa2 Responsible for authoring and documenting business requirements and providing analytical support and expertise needed to translate requirements into solutions.xe2x9exa2 Should be able to create and maintain Data Mapping Specifications for Saama Data Review Model.xe2x9exa2 Should incorporate feedback and input from customers, partners and in-house teams on productxe2x9exa2 Should manage and assume accountability for all aspects of projects related to implementation including:xe2x96xa0 Guiding the client through release planning in support of the overall project.xe2x96xa0 Managing communication throughout the team and stakeholders. Lead product implementation efforts coordinating with customers, product SME and other teamsxe2x96xa0 Managing the quality of project team deliverables.xe2x96xa0 Documenting and reporting status and issues.xe2x96xa0 Identifying, reporting and managing risks; overcoming project obstacles.xe2x96xa0 Acting as a client liaison and representative communicating client feedback to appropriate representatives; acting to resolve outstanding issues on behalf of client in a timely manner.xe2x9exa2 Should ensure a smooth transition of services from implementation to support.xe2x9exa2 Should provide advanced analytical and reporting support to customers on various projects. Solves complex problems and / or conducts complex analysis.xe2x9exa2 Should support configuration and quality check with project teams to ensure solution will meet the business objectives of the requirements.xe2x9exa2 Should be able to help identify and define new sources of relevant data, Analyzing data and make recommendation.xe2x9exa2 Should support customer UAT phase for any configuration change or issue triaging.xe2x9exa2 Should understand and can discuss the application and implications of changes to process, and relation to requirements.xe2x9dx96Desired Skillsxe2x9exa2 Experience in the Pharmaceutical industry is essentialxe2x9exa2 Good understanding of one or more of the following Clinical Systemsxe2x96xa0 EDC Systems such as Medidata Rave, Veeva EDC, Oracle InForm, etc.,xe2x96xa0 CTMS Systems such as Siebel CTMS, Medidata CTMS,Veeva CTMS, etc.,xe2x96xa0 IRT Systems such as YPRIME, Parexel Clinphone, etc.,xe2x96xa0 LAB Systems such as central Lab, local Labs etc.,xe2x9exa2 Good experience in SQLxe2x9exa2 Good understanding of clinical trial domain & overall EDC study setup & Clinical reportingxe2x9exa2 Good understanding and experience in building Clinical reports and dashboardsxe2x9exa2 Good understanding of CDASH, SDTM and ADAM standards.xe2x9exa2 Relevant degrees such as Bachelor's and Master's Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - Bachelor's degree (BA) in computer science, or equivalent work experience required.xe2x9exa2 1-2 years of experience as a Product Owner.xe2x9exa2 Comfortable and familiar with the Agile Working Environment.xe2x9exa2 Experience working with all phases of SDLCxe2x9exa2 Familiarity with FDA regulations such as 21 CFR Part 11 and GxP is a bonusxe2x9exa2 Experience working in the complete product life cycle of two or more products.xe2x9exa2 Should have technical knowledge that includes knowledge of Software Development and Web Development.xe2x9exa2 Experience with use and configuration of healthcare software applications (preferably clinical

Saama Technologies