Job Description

Responsible for creating URS and functional requirement specs in Clinical Reporting and Analytics Create wire-frames and mock-ups for Clinical reports Responsible for communicating with Clinical Data Management & Medical Reviewers and document the clinical reporting needs. Should be up-to-date with all the Saama product features and releases. Should analyze and understand current business processes, events and flows in Clinical Trial Development Should be responsible for Clinical Project Support and acts as a Clinical Subject Matter Expert Responsible for authoring and documenting business requirements and providing analytical support and expertise needed to translate requirements into solutions. Should be able to create and maintain Data Mapping Specifications for Saama Data Review Model. Should incorporate feedback and input from customers, partners and in-house teams on product 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. Should ensure a smooth transition of services from implementation to support. Should provide advanced analytical and reporting support to customers on various projects. Solves complex problems and / or conducts complex analysis. Should support configuration and quality check with project teams to ensure solution will meet the business objectives of the requirements. Should be able to help identify and define new sources of relevant data, Analyzing data and make recommendation. Should support customer UAT phase for any configuration change or issue triaging. Should understand and can discuss the application and implications of changes to process, and relation to requirements.xe2x9dx96Desired Skills Experience in the Pharmaceutical industry is essential 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., Good experience in SQL Good understanding of clinical trial domain & overall EDC study setup & Clinical reporting Good understanding and experience in building Clinical reports and dashboards Good understanding of CDASH, SDTM and ADAM standards. 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. 1-2 years of experience as a Product Owner. Comfortable and familiar with the Agile Working Environment. Experience working with all phases of SDLC Familiarity with FDA regulations such as 21 CFR Part 11 and GxP is a bonus Experience working in the complete product life cycle of two or more products. Should have technical knowledge that includes knowledge of Software Development and Web Development. Experience with use and configuration of healthcare software applications (preferably clinical

Saama Technologies