Job
Description
As an Implementation Consultant at our company, your role will involve the following key responsibilities: - Responsible for creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. - Create wire-frames and mock-ups for Clinical reports. - Communicate with Clinical Data Management & Medical Reviewers to document the clinical reporting needs. - Stay up-to-date with all Saama product features and releases. - Analyze and understand current business processes, events, and flows in Clinical Trial Development. - Act as a Clinical Subject Matter Expert and provide Clinical Project Support. - Author and document business requirements, providing analytical support needed to translate requirements into solutions. - Create and maintain Data Mapping Specifications for Saama Data Review Model. - Incorporate feedback from customers, partners, and in-house teams on product. - Manage all aspects of projects related to implementation including guiding the client through release planning, managing communication, leading product implementation efforts, managing project team deliverables, documenting and reporting status and issues, identifying and managing risks, and acting as a client liaison. - Ensure a smooth transition of services from implementation to support. - Provide advanced analytical and reporting support to customers on various projects, solving complex problems and conducting complex analysis. - Support configuration and quality check with project teams to ensure the solution meets business objectives. - Help identify and define new sources of relevant data, analyze data, and make recommendations. - Support customer User Acceptance Testing (UAT) phase for any configuration change or issue triaging. - Understand and discuss the application and implications of changes to the process and relation to requirements. Desired Skills: - Experience in the Pharmaceutical industry is essential. - Good understanding of Clinical Systems such as EDC Systems (Medidata Rave, Veeva EDC, Oracle InForm, etc.), CTMS Systems (Siebel CTMS, Medidata CTMS, Veeva CTMS, etc.), IRT Systems (YPRIME, Parexel Clinphone, etc.), and LAB Systems (central Lab, local Labs, etc.). - Good experience in SQL. - Good understanding of the clinical trial domain, overall EDC study setup, and Clinical reporting. - Experience in building Clinical reports and dashboards. - 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 Software Development Life Cycle (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. - Technical knowledge including knowledge of Software Development and Web Development. - Experience with use and configuration of healthcare software applications (preferably clinical). As an Implementation Consultant at our company, your role will involve the following key responsibilities: - Responsible for creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. - Create wire-frames and mock-ups for Clinical reports. - Communicate with Clinical Data Management & Medical Reviewers to document the clinical reporting needs. - Stay up-to-date with all Saama product features and releases. - Analyze and understand current business processes, events, and flows in Clinical Trial Development. - Act as a Clinical Subject Matter Expert and provide Clinical Project Support. - Author and document business requirements, providing analytical support needed to translate requirements into solutions. - Create and maintain Data Mapping Specifications for Saama Data Review Model. - Incorporate feedback from customers, partners, and in-house teams on product. - Manage all aspects of projects related to implementation including guiding the client through release planning, managing communication, leading product implementation efforts, managing project team deliverables, documenting and reporting status and issues, identifying and managing risks, and acting as a client liaison. - Ensure a smooth transition of services from implementation to support. - Provide advanced analytical and reporting support to customers on various projects, solving complex problems and conducting complex analysis. - Support configuration and quality check with project teams to ensure the solution meets business objectives. - Help identify and define new sources of relevant data, analyze data, and make recommendations. - Support customer User Acceptance Testing (UAT) phase f
