Implementation Lead

Description
Implementation Consultant - JD
Reports to: Product Owner

• 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 Clients 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 SOPs, 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 , APIs 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