Implementation Lead

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