Implementation Lead
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.
■ Manage communication throughout the team and stakeholders.
■ Lead product implementation efforts coordinating with customers, product SME and other teams
■ Manage the quality of Implementation deliverables.
■ Document and report status on Risks,Issues, Actions and Decisions.
■ Identify, report and manage 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 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.
➢ 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