Implementation Lead

Job Description

Description Implementation Consultant - JD Reports to: Product Owner Job Description Key Responsibilities Should manage and assume accountability for all aspects of projects related to implementation including: Guiding the client through release planning in support of the overall project. Manag e communication throughout the team and stakeholders. Lead product implementation efforts coordinating with customers, product SME and other teams Mana ge the quality of Implementation deliverables. Document and report status on Risks,Issues, Actions and Decisions . Identify, report and manag e risks; overcoming project obstacles. Act 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. Understand Client s clinical landscape and provide techno-functional solutions to evolving needs of the clients. Should analyze and understand current business processes, events and flows in Clinical Trial Development and create SOP s, Work instructions for implementation /delivery team team. Should ensure a smooth transition of services from implementation to support Should incorporate feedback and input from customers, partners and in-house teams on saama product features 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 understand and can discuss the application and implications of changes to process, and relation to requirements. Desired Skills Experience in the Lifesciences and Pharmaceutical industry is essential Good experience in SQL , API s and Integrations Good understanding of CDASH, SDTM and ADAM standards. Good understanding of one or more of the following Clinical Systems EDC Systems such as Medidata Rave, Veeva EDC, Oracle InForm, etc., CTMS Systems such as Siebel CTMS, Medidata CTMS,Veeva CTMS, etc., IRT Systems such as YPRIME, Parexel Clinphone, etc., LAB Systems such as central Lab, local Labs etc., Good understanding of clinical trial domain overall EDC study setup Clinical reporting Good understanding and experience in building Clinical reports and dashboards Relevant degrees such as Bachelors and Masters Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - Bachelors degree (BA) in computer science, or equivalent work experience required. 3-5 years of experience as a Product Manager or 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